Approved Oncology Drugs - Gabrail Cancer & Research Center

2019

Niraparib (ZEJULA) Tesaro, Inc., for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD)-positive status.
Daratumumab (DARZALEX) Janssen, for adult patients with multiple myeloma in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant (ASCT).
Apalutamide (ERLEADA) Janssen Biotech, Inc, for patients with metastatic castration-sensitive prostate cancer (mCSPC).
Pembrolizumab (KEYTRUDA) Merck, plus lenvatinib (LENVIMA) Eisai, for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) and who have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation.
Fedratinib (INREBIC) Impact Biomedicines, Inc., for adults with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF).
Entrectinib (ROZLYTREK) Genentech Inc., for solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory standard therapy.
Pexidartinib (TURALIO™) Daiichi Sankyo, for tenosynovial giant cell tumor.
Pembrolizumab (KEYTRUDA) Merck, for advanced esophageal squamous cell cancer.
Darolutamide (NUBEQA) Bayer HealthCare Pharmaceuticals Inc., for non-metastatic castration-resistant prostate cancer.
Selinexor (XPOVIO) Karyopharm Therapeutics, in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.
Daratumumab (DARZALEX) Janssen Biotech, Inc., in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
Pembrolizumab (KEYTRUDA) Merck, for patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.
Pembrolizumab (KEYTRUDA) Merck, for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC).
Polatuzumab vedotin-piiq (POLIVY) Genentech, Inc., a CD79b-directed antibody-drug conjugate indicated in combination with bendamustine and a rituximab product for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
Gilteritinib (XOSPATA) Astellas Pharma US, Inc, for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation.
Lenalidomide (REVLIMID) Celgene Corp., in combination with a rituximab product for previously treated follicular lymphoma (FL) and previously treated marginal zone lymphoma (MZL).
Alpelisib (PIQRAY) Novartis Pharmaceuticals Corporation, in combination with fulvestrant for postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.
Ruxolitinib (JAKAFI) Incyte Corporation, for steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older.
Dalteparin sodium (FRAGMIN) Pfizer, Inc., to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients 1 month of age and older.
Venetoclax (VENCLEXTA) AbbVie Inc. and Genentech Inc., for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Avelumab (BAVENCIO) EMD Serono, Inc., in combination with axitinib for first-line treatment of patients with advanced renal cell carcinoma (RCC).
Ramucirumab (CYRAMZA) Eli Lilly and Company, as a single agent for hepatocellular carcinoma (HCC) in patients who have an alpha fetoprotein (AFP) of ≥ 400 ng/mL and have been previously treated with sorafenib.
Ado-trastuzumab emtansine (KADCYLA) Genentech, Inc., for the adjuvant treatment of patients with HER2-positive early breast cancer (EBC) who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment.
Ivosidenib (TIBSOVO) Agios Pharmaceuticals, Inc., for newly-diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation.
Pembrolizumab (KEYTRUDA) Merck & Co. Inc., plus axitinib for first-line treatment of patients with advanced renal cell carcinoma (RCC).
Erdafitinib (BALVERSA) Janssen Pharmaceutical Companies, for locally advanced or metastatic urothelial carcinoma, with susceptible FGFR3 or FGFR2 genetic alterations, that has progressed during or following platinum-containing chemotherapy.
Pembrolizumab (KEYTRUDA) Merck Inc., for first-line treatment of patients with stage III non-small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation or metastatic NSCLC.
Atezolizumab (TECENTRIQ) Genentech Inc., in combination with carboplatin and etoposide, for first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
Atezolizumab (TECENTRIQ) Genentech Inc., for PD-L1 positive unresectable locally advanced or metastatic triple-negative breast cancer.
Trastuzumab and hyaluronidase-oysk injection (Herceptin Hylecta) Genentech Inc., for the treatment of HER2 overexpressing breast cancer.
Trifluridine/ tipiracil tablets (LONSURF) Taiho Pharmaceutical Co., Ltd, for adult patients with metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma previously treated with at least two prior lines of chemotherapy.
Pembrolizumab (KEYTRUDA) Merck, for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.
Caplacizumab-yhdp (CABLIVI) Ablynx NV, for adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.
Cabozantinib (CABOMETYX) Exelixis, Inc. for hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
Darolutamide (NUBEQA) Bayer HealthCare Pharmaceuticals Inc; for non-metastatic castration-resistant prostate cancer.

2018

Tagraxofusp-erzs (ELZONRIS™) Stemline Therapeutics; a CD123-directed cytotoxin, for blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older. December 21, 2019
Ravulizumab-cwvz (ULTOMIRIS™) Alexion Pharmaceuticals, Inc.; for adult patients with paroxysmal nocturnal hemoglobinuria (PNH). December 21, 2018
Calaspargase pegol-mknl (ASPARLAS) Servier Pharmaceuticals LLC; an asparagine specific enzyme, as a component of a multi-agent chemotherapeutic regimen for acute lymphoblastic leukemia (ALL) in pediatric and young adult patients age 1 month to 21 years.December 20, 2018
Olaparib (LYNPARZA) AstraZeneca Pharmaceuticals LP; for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. December 19, 2018
Pembrolizumab (KEYTRUDA) Merck & Co. Inc.; for adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma. December 19, 2018.
Herzuma (trastuzumab-pkrb) Celltrion Inc.; for patients with HER2-overexpressing breast cancer. December 14, 2018
Romiplostim (NPLATE) Amgen Inc.; for pediatric patients 1 year of age and older with immune thrombocytopenia (ITP) December 14, 2018
Atezolizumab (TECENTRIQ) Genentech, Inc.; in combination with bevacizumab, paclitaxel, and carboplatin for the first-line treatment of patients with metastatic non-squamous, non-small cell lung cancer. December 6, 2018
Gilteritinib (XOSPATA) Astellas Pharma US Inc.; for treatment of adult patients who have relapsed or refractory acute myeloid leukemia. November 28, 2018
Truxima (rituximab-abbs) Celltrion Inc.; for patients with CD20-positive, B-cell non-Hodgkin’s lymphoma. November 28, 2018
Larotrectinib (VITRAKVILoxo) Oncology Inc. and Bayer; for adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase gene fusion without a known acquired resistance mutation. November 26, 2018
Venetoclax (VENCLEXTA) AbbVie Inc. and Genentech Inc.; for the treatment of newly-diagnosed acute myeloid leukemia. November 21, 2018
Glasdegib (DAURISMO) Pfizer Labs; for newly-diagnosed acute myeloid leukemia. November 21, 2018
Emapalumab (GAMIFANT) Novimmune SA; for adult and pediatric patients with primary hemophagocytic lymphohistiocytosis. November 20, 2018
Brentuximab vedotin (ADCETRIS) Seattle Genetics Inc.; for previously untreated systemic anaplastic large cell lymphoma or other CD30-expressing peripheral T-cell lymphomas. November 16, 2018
Pembrolizumab (KEYTRUDA) Merck & Co. Inc.; for patients with hepatocellular carcinoma. November 9, 2018
Lorlatinib (LORBRENA) Pfizer, Inc.; for patients with anaplastic lymphoma kinase positive metastatic non-small cell lung cancer. November 2, 2018
Pembrolizumab (KEYTRUDA) Merck & Co. Inc.; as first-line treatment of metastatic squamous non-small cell lung cancer. October 30, 2018
Talazoparib (TALZENNA) Pfizer Inc.; for locally advanced or metastatic breast cancer. October 16, 2018.
Emicizumab-kxwh injection (HEMLIBRA) Genentech, Inc.Genentech, Inc.; to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia. October 4, 2018
Cemiplimab-rwlc (LIBTAYO) Regeneron Pharmaceuticals Inc.; for patients with metastatic cutaneous squamous cell carcinoma or locally advanced CSCC who are not candidates for curative surgery or curative radiation. September 28, 2018.
FDA approved dacomitinib tablets (VIZIMPRO, Pfizer Pharmaceutical Company) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test. More Information. September 27, 2018
FDA granted regular approval to duvelisib (COPIKTRA, Verastem, Inc.) for adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies. In addition, duvelisib received accelerated approval for adult patients with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. More Information. September 24, 2018
FDA approved moxetumomab pasudotox-tdfk (LUMOXITI, AstraZeneca Pharmaceuticals LP), a CD22-directed cytotoxin indicated for adult patients with relapsed or refractory hairy cell leukemia (HCL) who received at least two prior systemic therapies, including treatment with a purine nucleoside analog (PNA). More Information. September 13, 2018
FDA approved pembrolizumab (KEYTRUDA, Merck & Co., Inc.) in combination with pemetrexed and platinum as first-line treatment of patients with metastatic, non-squamous non-small cell lung cancer (NSqNSCLC), with no EGFR or ALK genomic tumor aberrations. More Information. August 20, 2018.
FDA updated the prescribing information for Keytruda (pembrolizumab) and Tecentriq (atezolizumab) to require the use of an FDA-approved companion diagnostic test to determine PD-L1 levels in tumor tissue from patients with locally advanced or metastatic urothelial cancer who are cisplatin-ineligible. FDA approved two different companion diagnostic tests, one for use with Keytruda and one for use with Tecentriq, More Information. August 16, 2018.
FDA granted accelerated approval to nivolumab (Opdivo, Bristol-Myers Squibb Company Inc.) for patients with metastatic small cell lung cancer (SCLC) with progression after platinum-based chemotherapy and at least one other line of therapy. More Information. August 16, 2018
FDA approved lenvatinib capsules (Lenvima, Eisai Inc.) for first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). More Information. August 16, 2018
FDA approved mogamulizumab-kpkc (Poteligeo, Kyowa Kirin, Inc.) for adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy. More Information. August 8, 2018
FDA approved lusutrombopag (Mulpleta, Shionogi Inc.) for thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure. More Information. July 31, 2018.
FDA approved iobenguane I 131 (AZEDRA, Progenics Pharmaceuticals, Inc.) for adult and pediatric patients (12 years and older) with iobenguane scan-positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma (PPGL) who require systemic anticancer therapy. More Information. July 30, 2018.
FDA approved ivosidenib (Tibsovo, Agios Pharmaceuticals, Inc.) for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test. More Information. July 20, 2018
FDA expanded the indication for ribociclib (Kisqali, Novartis Pharmaceuticals Corporation) in combination with an aromatase inhibitor for pre/perimenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy. More Information. July 18, 2018
FDA approved enzalutamide (XTANDI, Astellas Pharma US, Inc.), for patients with castration-resistant prostate cancer (CRPC). More Information. July 13, 2018
FDA granted accelerated approval to ipilimumab (YERVOY, Bristol-Myers Squibb Company Inc.) for use in combination with nivolumab for the treatment of patients 12 years of age and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. More Information. July 10, 2018
FDA has limited the use of Tecentriq and Keytruda for patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing therapy. More Information. June 19, 2018
FDA approved encorafenib and binimetinib (BRAFTOVI and MEKTOVI, Array BioPharma Inc.) in combination for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. More Information. June 27, 2018
FDA granted accelerated approval to pembrolizumab (Keytruda, Merck) for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after two or more prior lines of therapy. More Information. June 13, 2018
FDA approved bevacizumab (Avastin, Genentech, Inc.) for patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with carboplatin and paclitaxel, followed by single-agent bevacizumab, for stage III or IV disease after initial surgical resection. More Information. June 13, 2018
FDA approved pembrolizumab (Keytruda, Merck and Co. Inc.) for patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. More Information. June 12, 2018
FDA granted regular approval to venetoclax (VENCLEXTA, AbbVie Inc. and Genentech Inc.) for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy. More Information. June 8, 2018
FDA approved methoxy polyethylene glycol-epoetin beta (Mircera, Vifor Pharma Inc.) for the treatment of pediatric patients 5 to 17 years of age on hemodialysis who are converting from another ESA after their hemoglobin level was stabilized with an ESA. More Information. June 7, 2018
FDA approved Fulphila (pegfilgrastim-jmdb, Mylan GmbH) as a biosimilar to Neulasta (pegfilgrastim, Amgen, Inc.) to decrease the chance of infection as suggested by febrile neutropenia in patients with non-myeloid cancer who are receiving myelosuppressive chemotherapy that has a clinically significant incidence of febrile neutropenia. More Information. June 4, 2018
FDA approved avatrombopag (Doptelet, AkaRx Inc.) for thrombocytopenia in adults with chronic liver disease scheduled to undergo a procedure. More Information. May 21, 2018
FDA approved Retacrit (epoetin alfa-epbx, Hospira Inc., a subsidiary of Pfizer Inc.) as a biosimilar to Epogen/Procrit (epoetin alfa, Amgen Inc.) for the treatment of anemia due to chronic kidney disease (CKD) in patients on dialysis and not on dialysis, use of zidovudine in patients with HIV infection, and the effects of concomitant myelosuppressive chemotherapy. It is also approved for the reduction of allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery. More Information. May 15, 2018
FDA approves dabrafenib plus trametinib for anaplastic thyroid cancer with BRAF V600E mutation. More Information. May 4, 2018.
FDA approved tisagenlecleucel (KYMRIAH, Novartis Pharmaceuticals Corp.) a CD19-directed genetically modified autologous T-cell immunotherapy, for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma. More Information. May 1, 2018.
FDA granted regular approval to dabrafenib (TAFINLAR, Novartis Pharmaceuticals Corp.) and trametinib (MEKINIST, Novartis Pharmaceuticals Corp.) in combination for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection. More Information. April 30, 2018
FDA approved osimertinib (Tagrisso, AstraZeneca Pharmaceuticals LP) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. More Information. April 19, 2018
FDA approved fostamatinib disodium hexahydrate tablets (TAVALISSE, Rigel Pharmaceuticals, Inc.) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. More Information. April 17, 2018
FDA granted approvals to nivolumab and ipilimumab (Opdivo and Yervoy, Bristol-Myers Squibb Co.) in combination for the treatment of intermediate or poor risk, previously untreated advanced renal cell carcinoma. More Information. April 16, 2018
FDA approved everolimus tablets for oral suspension (Afinitor Disperz, Novartis Pharmaceuticals Corp.) for the adjunctive treatment of adult and pediatric patients aged 2 years and older with tuberous sclerosis complex (TSC)-associated partial-onset seizures. Everolimus is also approved for two other manifestations of TSC: TSC-associated subependymal giant cell astrocytoma (SEGA) and TSC-associated renal angiomyolipoma. More Information. April 10, 2018
FDA approved rucaparib for maintenance treatment of recurrent ovarian, fallopian tube, or primary peritoneal cancer. More Information. April 6, 2018
FDA granted accelerated approval to blinatumomab (Blincyto, Amgen Inc.) for the treatment of adult and pediatric patients with B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. More Information. March 29, 2018
FDA approved nilotinib (TASIGNA, Novartis Pharmaceuticals Corporation) for pediatric patients 1 year of age or older with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy. More Information. March 22, 2018
FDA approved brentuximab vedotin (Adcetris, Seattle Genetics, Inc.) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy. More Information. March 20, 2018
FDA approved abemaciclib (VERZENIO, Eli Lilly and Company) in combination with an aromatase inhibitor as initial endocrine-based therapy for postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. More Information. February 26, 2018
FDA approved durvalumab (Imfinzi, AstraZeneca Inc.) for patients with unresectable stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. More Information. February 16, 2018
FDA approves apalutamide for non-metastatic castration-resistant prostate cancer. More Information. February 14, 2018
FDA approved abiraterone acetate (Zytiga, Janssen Biotech Inc.) tablets in combination with prednisone for metastatic high-risk castration-sensitive prostate cancer (CSPC). More Information. February 7, 2018
FDA approved lutetium Lu 177 dotatate (LUTATHERA, Advanced Accelerator Applications USA, Inc.) a radiolabeled somatostatin analog, for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults. More Information. January 26, 2018
FDA granted approval to afatinib (Gilotrif, Boehringer Ingelheim Pharmaceutical, Inc.) for a broadened indication in first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test. More Information. January 12, 2018
FDA granted regular approval to olaparib tablets (Lynparza, AstraZeneca Pharmaceuticals LP), a poly (ADP-ribose) polymerase (PARP) inhibitor, for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative metastatic breast cancer who have been treated with chemotherapy either in the neoadjuvant, adjuvant, or metastatic setting. More Information. January 12, 2018

2017

Pertuzumab – (PERJETA); Genentech, Inc.; for treatment of HER2-positive early breast cancer. Approved December 2017
Nivolumab – (OPDIVO); Bristol-Myers Squibb; for treatment of melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. Approved December 2017
Bosutinib – (BOSULIF); Pfizer Inc.; for treatment of newly-diagnosed chronic phase, Philadelphia chromosome positive, chronic myelogenous leukemia (CML). Approved December 2017
Cabozantinib – (Cabometyx); Exelixis, Inc.; for treatment of advanced renal cell carcinoma (RCC). Approved December 2017.
Ogivri – (trastuzumab-dkst); Mylan; for the treatment of HER2-overexpressing breast or metastatic stomach cancer Approved December 2017
FoundationOne CDx – (F1CDx); Foundation Medicine, Inc.; in vitro diagnostic to detect genetic mutations in 324 genes and two genomic signatures in any solid tumor type. Approved November 2017
Sunitinib Malate – (Sutent); Pfizer Inc.; for treatment of recurrent renal cell carcinoma following nephrectomy. Approved November 2017
Obinutuzumab – (GAZYVA); Genentech, Inc.; for the treatment previously untreated stage II bulky, III, or IV follicular lymphoma. Approved November 2017
Brentuximab Vedotin – (ADCETRIS); Seattle Genetics, Inc.; for treatment of primary cutaneous anaplastic large cell lymphoma or CD30-expressing mycosis fungoides. Approved November 2017.
Alectinib – (ALECENSA); Hoffmann-La Roche, Inc./Genentech, Inc.; for treatment of anaplastic lymphoma kinase positive metastatic non-small cell lung cancer. Approved November 2017
Acalabrutinib – (Calquence); AstraZeneca Pharmaceuticals Inc. under license of Acerta Pharma BV; for treatment of mantle cell lymphoma Approved October 2017
Axicabtagene Ciloleucel – (YESCARTA); Kite Pharma, Inc.; for treatment relapsed or refractory large B-cell lymphoma. Approved October 2017
Abemaciclib – (VERZENIO); Eli Lilly and Company;for treatment of HR-positive, HER2-negative advanced or metastatic breast cancer. Approved September 2017
Nivolumab – (OPDIVO); Bristol-Myers Squibb Co.; for the treatment of hepatocellular carcinoma. Approved September 2017
Pembrolizumab – (KEYTRUDA); Merck & Co., Inc.; for treatment of locally advanced or metastatic, gastric or gastroesophageal junction adenocarcinoma Approved September 2017
Cabazitaxel – (JEVTANA); Sanofi-Aventisin; for treatment metastatic castration-resistant prostate cancer. Approved September 2017
Copanlisib – (ALIQOPA); Bayer HealthCare Pharmaceuticals Inc.; for treatment of relapsed follicular lymphoma. Approved September 2017
Mvasi (bevacizumab-awwb); Amgen Inc.; for treatment of cancer. Approved September 2017
Gemtuzumab Ozogamicin – (Mylotarg); Pfizer Inc.; for treatment of newly-diagnosed CD33-positive acute myeloid leukemia and relapsed or refractory CD33-positive AML Approved September2017
Tisagenlecleucel – (KYMRIAH); Novartis Pharmaceuticals Corp.; for treatment B-cell precursor acute lymphoblastic leukemia. Approved August 2017
Olaparib tablets (Lynparza); AstraZenecafor; for treatment recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. Approved August 2017
Inotuzumab Ozogamicin – (BESPONSA); Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.; for treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia Approved August 2017
Liposome-encapsulated combination of Daunorubicin and Cytarabine – (VYXEOS); Jazz Pharmaceuticals, Inc.; for treatment of newly-diagnosed therapy-related AML or AML with myelodysplasia-related changes. Approved August 2017
Ibrutinib – (Imbruvica); Pharmacyclics LLC; for treatment of chronic graft versus host disease. Approved August 2017
Enasidenib – (IDHIFA); Celgene Corp.; for treatment of relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase-2. Approved August 2017
Nivolumab – (OPDIVO); Bristol-Myers Squibb Company; for treatment of mismatch repair deficient and microsatellite instability high metastatic colorectal cancer. Approved August 2017
Neratinib – (NERLYNX); Puma Biotechnology, Inc.; for treatment of early stage HER2-overexpressed/amplified breast cancer. Approved July 2017
Blinatumomab – (BLINCYTO); Amgen Inc.; for treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia. Approved July 2017
Praxis Extended RAS Panel – Illumina, Inc.; a next generation sequencing test to detect certain genetic mutations in RAS genes in tumor samples of patients with metastatic colorectal cancer. Appproved June 2017
Betrixaban – (BEVYXXA); Portolafor; the prophylaxis of venous thromboembolism. Approved June 2017
Dabrafenib and Trametinib – (TAFINLAR and MEKINIST); Novartis Pharmaceuticals Inc.; for treatment of metastatic non-small cell lung cancer with BRAF V600E mutation. Approved June 2017
Rituximab and Hyaluronidase – (RITUXAN HYCELA); Genentech Inc.; for treatment of follicular lymphoma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia. Approved June 2017
Ceritinib – (ZYKADIA); Novartis Pharmaceuticals Corp.; for treatment of metastatic non-small cell lung cancer whose tumors are anaplastic lymphoma kinase positive. Approved May 2017
Pembrolizumab – (KEYTRUDA); Merck & Co.; for treatment of unresectable or metastatic, microsatellite instability-high or mismatch repair deficient solid tumors. Approved May 2017
Pembrolizumab – (KEYTRUDA); Merck and Co., Inc.; for treatment of locally advanced or metastatic urothelial carcinoma. Approved May 2017
Pembrolizumab – (KEYTRUDA); Merck and Co., Inc.; for treatment of metastatic non-squamous non-small cell lung cancer. Approved May 2017
Avelumab – (BAVENCIO); EMD Serono, Inc.; for treatment of locally advanced or metastatic urothelial carcinoma. Approved May 2017
Durvalumab – (IMFINZI); AstraZeneca UK Limited; for treatment of locally advanced or metastatic urothelial carcinoma. Approved May 2017
Brigatinib (ALUNBRIG); Takeda Pharmaceutical Company Limited, through its wholly owned subsidiary ARIAD Pharmaceuticals, Inc.; for treatment of metastatic anaplastic lymphoma kinase positive non-small cell lung cancer. Approved April 2017
Midostaurin – (RYDAPT); Novartis Pharmaceuticals Corp.; for treatment of newly diagnosed acute myeloid leukemia who are FLT3 mutation-positive. Approved April 2017
Regorafenib – (STIVARGA); Bayer HealthCare Pharmaceuticals Inc; for treatment of hepatocellular carcinoma. Approved April 2017
Philips IntelliSite Pathology Solution (PIPS); Philips Medical Systems Nederland B.V.; as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded. Approved April 2017
Ipsogen JAK2 RGQ PCR Kit – QIAGEN GmbH.; to detect mutations affecting the Janus Tyrosine Kinase 2 gene. Approved March 2017
Palbociclib – (IBRANCE); Pfizer Inc.; for treatment of hormone receptor positive human epidermal growth factor receptor 2 negative advanced or metastatic breast cancer. Approved March 2017
Osimertinib – (TAGRISSO); AstraZeneca Pharmaceuticals, LP; for treatment of metastatic epidermal growth factor receptor T790M mutation-positive non-small cell lung cancer. Approved March 2017
Niraparib – (ZEJULA); Tesaro, Inc.; for treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. Approved March 2017
Avelumab – (BAVENCIO); EMD Serono, Inc.; for treatment of metastatic Merkel cell carcinoma. Approved March 2017
Pembrolizumab – (KEYTRUDA); Merck and Co., Inc.; for treatment of refractory classical Hodgkin lymphoma or those who have relapsed after three or more prior lines of therapy. Approved March 2017
Ribociclib – (KISQALI); Novartis Pharmaceuticals Corp.; for treatment of postmenopausal hormone receptor positive human epidermal growth factor receptor 2 negative advanced or metastatic breast cancer. Approved March 2017
Lenalidomide – (Revlimid); Celgene Corp.; for treatment of multiple myeloma following autologous stem cell transplant. Approved February 2017
Nivolumab – (OPDIVO); Bristol-Myers Squibb Company; for treatment of locally advanced or metastatic urothelial carcinoma. Approved February 2017

2016

Rubraca – (rucaparib); Clovis Oncology; For the treatment of women with a certain type of ovarian cancer
Lartruvo – (olaratumab); Eli Lilly; For the treatment of adults with certain types of soft tissue sarcoma
Tecentriq – (atezolizumab); Genentech; For the treatment of urothelial carcinoma, the most common type of bladder cancer
Venclexta – (venetoclax); Abbvie and Genetech; For the treatment of chronic lymphocytic leukemia in patients with a specific chromosomal abnormality

2015

Cotellic – (cobimetinib); Genentech; For the treatment of BRAF V600E or V600K melanoma, Approved November 2015
Darzalex- (daratumumab); Janssen Biotech; For the treatment of multiple myeloma, Approved November 2015
Imlygic – (talimogene laherparepvec); Amgen; For the treatment of unresectable recurrent melanoma, Approved October 2015
Lonsurf – (trifluridine and tipiracil); Taiho Oncology; For the treatment of metastatic colorectal cancer , Approved September 2015
Opdivo – (nivolumab); Bristol-Myers Squibb; For the treatment of metastatic squamous non-small cell lung cancer, Approved March 2015

2014

Azynzeo – (netupitant and palonosetron);Helsinn; For the prevention of chemotherapy-induced nausea and vomiting, Approved October 2014
Imbruvica – (ibrutunib); Pharmacyclics; For the treatment of chronic lymphocytic leukemia, Approved February 2014
Lynparza – (olaparib); AstraZeneca; For the treatment of previously treated BRCA mutated advanced ovarian cancer, Approved December 2014
Opdivo – (nivolumab); Bristol-Myers Squibb; For the treatment of unresectable or metastatic melanoma, Approved December 2014
Zydelig – (idelalisib);Gilead; For the treatment of relapsed CLL, follicular B-cell NHL and small lymphocytic lymphoma, Approved July 2014

2013

Gilotrif – (afatinib); Boehringer Ingelheim; For the treatment of metastatic non-small cell lung cancer with EGFR mutations
Imbruvica – (ibrutinib);Pharmacyclics; For the treatment of mantle cell lymphoma, Approved November of 2013
Pomalyst – (pomalidomide); Celgene; For the treatment of relapsed and refractory multiple myeloma
Stivarga – (regorafenib); Bayer; For the treatment of gastrointestinal stromal tumor

2012

Subsys – (fentanyl sublingual spray); Insys Therapeutics; For the treatment of breakthrough cancer pain
Pertuzumab – (perjeta); Roche; For the treatment of HER2-positive metastatic breast cancer
Carfilzomib – (kyprolis); Onyx Pharmaceuticals; For the treatment of multiple myeloma
Ziv-aflibercept – (zaltrap); Sanofi; For the treatment of metastatic colorectal cancer

2011

Lazanda – (fentanyl citrate) nasal spray; Archimedes; For the management of breakthrough cancer pain
Zytiga – (abiraterone acetate); Centocor Ortho Biotech; For the treatment of prostate cancer

2010

Halaven – (eribulin mesylate); Eisai; For the treatment of metastatic breast cancer
Jevtana – (cabazitaxel) ; Sanofi Aventis; For the treatment of prostate cancer

2009

Onsolis – (fentanyl buccal); BioDelivery Sciences; For the management of breakthrough cancer pain
Afinitor – (everolimus); Novartis; For the treatment of renal cell carcinoma
Folotyn– (pralatrexate injection); Allos Therapeutics; For the treatment of peripheral T-cell lymphoma

2008

Sancuso – (granisetron); ProStrakan; For the treatment of chemotherapy-induced nausea and vomiting

2006

Sutent– (sunitinib); Pfizer; For the treatment of kidney cancer and gastrointestinal stromal tumors

2005

Nexavar – (sorafenib); Bayer/Onyx; For the treatment of Renal Cell Carcinoma

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