Oncology and Hematology Drug Approvals
New Drugs and Therapeutic Biological Products Approved by the U.S. Food and Drug Administration (FDA).
Approvals 2017
| INN | Trade Name / Company | Indication | Date |
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| Sunitinib malate | Sutent, Pfizer Inc. | adjuvant the treatment of adult patients at high risk of recurrent renal cell carcinoma following nephrectomy. | November 16, 2017 |
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| Obinutuzumab | GAZYVA, Genentech, Inc. | Indicated in combination with chemotherapy, followed by obinutuzumab monotherapy in patients achieving at least a partial remission, for the treatment of adult patients with previously untreated stage II bulky, III, or IV follicular lymphomas (FL). | November 16, 2017 |
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| Emicizumab-kxwh | HEMLIBRA, Genentech, Inc. | Indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors. | November 16, 2017 |
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| Dasatinib | SPRYCEL, Bristol-Myers Squibb Co. | Indicated for the treatment of pediatric patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase. | November 9, 2017 |
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| Brentuximab Vedotin | ADCETRIS, Seattle Genetics, Inc. | Indicated for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy. | November 9, 2017 |
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| Alectinib | ALECENSA, Hoffmann-La Roche, Inc./Genentech, Inc. | Indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC), as detected by an FDA-approved test. | November 6, 2017 |
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| Vemurafenib | ZELBORAF, Hoffmann-La Roche Inc. | Indicated for the treatment of patients with Erdheim-Chester Disease (ECD) with BRAF V600 mutation. | November 6, 2017 |
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| Acalabrutinib | Calquence, AstraZeneca Pharmaceuticals Inc. under license of Acerta Pharma BV | Indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. | October 31, 2017 |
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| Axicabtagene ciloleucel | YESCARTA, Kite Pharma, Inc | Indicated for the treatment of 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, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. | October 18, 2017 |
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| Abemaciclib | VERZENIO, Eli Lilly & Company | Indicated in combination with fulvestrant for women with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy. | September 28, 2017 |
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| Nivolumab | OPDIVO, Bristol-Myers Squibb Co | Indicated for the treatment of hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib. | September 22, 2017 |
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| Pembrolizumab | KEYTRUDA, Merck & Co., Inc. | Indicated for patients with recurrent locally advanced or metastatic, gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 as determined by an FDA-approved test. | September 22, 2017 |
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| Cabazitaxel | JEVTANA, Sanofi-Aventis | This indicated was approved at a lower dose of 20 mg/m2 every 3 weeks?in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen. Cabazitaxel (25 mg/m2 every 3 weeks) was approved for this indication in 2010. | September 14, 2017 |
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| Copanlisib | ALIQOPA, Bayer HealthCare Pharmaceuticals Inc. | Indicated for the treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies. | September 14, 2017 |
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| Bevacizumab-awwb | Mvasi, Amgen Inc. | A biosimilar to Avastin® (bevacizumab, Genentech Inc.). Mvasi is the first biosimilar approved in the U.S. for the treatment of cancer. | September 14, 2017 |
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| Gemtuzumab ozogamicin | Mylotarg, Pfizer Inc. | Indicated for the treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and, for treatment of relapsed or refractory CD33-positive AML in adults, and in pediatric patients 2 years and older. Gemtuzumab ozogamicin may be used in combination with daunorubicin and cytarabine for adults with newly-diagnosed AML or as a stand-alone treatment for certain adult and pediatric patients. | September 1, 2017 |
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| Tisagenlecleucel | KYMRIAH, Novartis Pharmaceuticals Corp. | Indicated for the treatment of patients up to age 25 years with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. | Regular approval. August 30, 2017 |
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| Olaparib tablets | Lynparza, AstraZeneca | Indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy. | Regular approval. August 17, 2017 |
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| Inotuzumab ozogamicin | BESPONSA, Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. | Indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). | August 17, 2017 |
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| A liposome-encapsulated combination of daunorubicin and cytarabine | VYXEOS, Jazz Pharmaceuticals, Inc. | Indicated for the treatment of adults with newly-diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC), two types of AML having a poor prognosis. | Regular approval. August 3, 2017 |
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| Ibrutinib | Imbruvica, Pharmacyclics LLC | Indicated for the treatment of adult patients with chronic graft versus host disease (cGVHD) after the failure of one or more lines of systemic therapy. This is the first FDA-approved therapy for the treatment of cGVHD. | August 2, 2017 |
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| Enasidenib | IDHIFA, Celgene Corp. | Indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test. | Regular approval. August 1, 2017 |
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| Nivolumab | OPDIVO, Bristol-Myers Squibb Company | Indicated for the treatment of patients 12 years and older with mismatch repair deficient (dMMR) and microsatellite instability-high (MSI-H) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. | Accelerated approval. August 1, 2017 |
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| Neratinib | NERLYNX, Puma Biotechnology, Inc. | Indicated for? the extended adjuvant treatment of adult patients with early-stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy. | July 17, 2017 |
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| Blinatumomab | BLINCYTO, Amgen Inc | Indicated for the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children. | July 11, 2017 |
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| L-glutamine oral powder | Endari, Emmaus Medical, Inc. | Indicated for oral administration to reduce the acute complications of sickle cell disease in adult and pediatric patients 5 years and older. | July 7, 2012 |
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| Praxis Extended RAS Panel | Illumina, Inc. | A next-generation sequencing (NGS) test to detect certain genetic mutations in RAS genes in tumor samples of patients with metastatic colorectal cancer (mCRC). The test is used to aid in the identification of patients who may be eligible for treatment with panitumumab (VECTIBIX, Amgen, Inc.). | Marketing approval. June 29, 2017 |
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| Betrixaban | BEVYXXA, Portola | Indicated for the prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE. | June 23, 2017 |
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| Dabrafenib and trametinib | TAFINLAR and MEKINIST, Novartis Pharmaceuticals Inc. | Administered in combination for patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test. | June 22, 2017 |
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| Rituximab and hyaluronidase human | RITUXAN HYCELA, Genentech Inc. | Indicated for adult patients with follicular lymphoma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia. | June 22, 2017 |
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| Aminolevulinic acid hydrochloride, known as ALA HCl | Gleolan, NX Development Corp | Approved as an optical imaging agent indicated in patients with gliomas (suspected World Health Organization Grades III or IV on preoperative imaging) as an adjunct for the visualization of malignant tissue during surgery. | June 6, 2017 |
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| Ceritinib | ZYKADIA, Novartis Pharmaceuticals Corp. | Indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. | May 26, 2017 |
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| Pembrolizumab | KEYTRUDA, Merck & Co. | Indicated for the treatment of adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options or with MSI-H or dMMR colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. | Accelerated approval. May 23, 2017 |
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| Pembrolizumab | KEYTRUDA, Merck and Co., Inc. | Indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. | Regular approval. May 18, 2017 |
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| Pembrolizumab | KEYTRUDA, Merck and Co., Inc. | Indicated, in combination with pemetrexed and carboplatin, for the treatment of patients with previously untreated metastatic non-squamous non-small cell lung cancer (NSCLC). | Accelerated approval. May 10, 2017 |
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| Avelumab | BAVENCIO, EMD Serono, Inc. | Indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. | Accelerated approval. May 9, 2017 |
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| Durvalumab | IMFINZI, AstraZeneca UK Limited | Indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. | Accelerated approval. May 1, 2017 |
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| Brigatinib | ALUNBRIG tablets, Takeda Pharmaceutical Company Limited, through its wholly-owned subsidiary ARIAD Pharmaceuticals, Inc. | Indicated for the treatment of patients with metastatic anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. | Accelerated approval. April 28, 2017 |
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| Midostaurin | RYDAPT, Novartis Pharmaceuticals Corp. | Indicated for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive (FLT3+), as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation. | April 28, 2017 |
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| Regorafenib | STIVARGA, Bayer HealthCare Pharmaceuticals Inc. | Expanded indication to include the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. | Expanded indication. April 27, 2017 |
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| Philips IntelliSite Pathology Solution | PIPS, Philips Medical Systems Nederland B.V. | Approved as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin-embedded (FFPE) tissue. | Marketing approval. April 17, 2017 |
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| ipsogen JAK2 RGQ PCR Kit | QIAGEN GmbH | Approved to detect mutations affecting the Janus Tyrosine Kinase 2 (JAK2) gene. This is the first FDA-authorized test intended to help physicians in evaluating patients for suspected Polycythemia Vera (PV). | Marketing authorization. March 27, 2017 |
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| Palbociclib | IBRANCE, Pfizer Inc. | Indicated for the treatment of hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women. | Regular approval. March 31, 2017 |
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| Osimertinib | TAGRISSO, AstraZeneca Pharmaceuticals, LP | Indicated for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy. | Regular approval. March 30, 2017 |
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| Niraparib | ZEJULA, Tesaro, Inc | A poly ADP-ribose polymerase (PARP) inhibitor, indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. | March 27, 2017 |
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| Avelumab | BAVENCIO, EMD Serono, Inc. | Indicated for the treatment of patients 12 years and older with metastatic Merkel cell carcinoma (MCC). Avelumab is a programmed death-ligand 1 (PD-L1) blocking human IgG1 lambda monoclonal antibody. This is the first FDA-approved product to treat this type of cancer. | Accelerated approval. March 23, 2017 |
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| Pembrolizumab | KEYTRUDA, Merck and Co., Inc. | Indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or those who have relapsed after three or more prior lines of therapy. | Accelerated approval. March 15, 2017 |
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| Ribociclib | KISQALI, Novartis Pharmaceuticals Corp. | A cyclin-dependent kinase 4/6 inhibitor, in combination with an aromatase inhibitor as initial endocrine-based therapy indicated for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. | March 13, 2017 |
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| Lenalidomide | Revlimid, Celgene Corp. | Indicated as maintenance therapy for patients with multiple myeloma following autologous stem cell transplant. | February 22, 2017 |
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| Nivolumab | OPDIVO, Bristol-Myers Squibb Company | Indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. | Accelerated approval. February 2, 2017 |
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Last Editorial Review: November 23, 2017
