Oncology & Hematology – FDA Drug Approvals 2017

?INNTrade Name / CompanyIndicationDate
Sunitinib malateSutent, Pfizer Inc.adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma following nephrectomy.November 16, 2017
ObinutuzumabGAZYVA, 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 lymphoma (FL).November 16, 2017
Emicizumab-kxwhHEMLIBRA, 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
DasatinibSPRYCEL, 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
Brentuximab VedotinADCETRIS, 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
AlectinibALECENSA, Hoffmann-La Roche, Inc./Genentech, Inc.Indicated for 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
VemurafenibZELBORAF, Hoffmann-La Roche Inc.Indicated for the treatment of patients with Erdheim-Chester Disease (ECD) with BRAF V600 mutation.November 6, 2017
AcalabrutinibCalquence, AstraZeneca Pharmaceuticals Inc. under license of Acerta Pharma BVIndicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.October 31, 2017
Axicabtagene ciloleucelYESCARTA, Kite Pharma, IncIndicated 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
AbemaciclibVERZENIO, Eli Lilly & CompanyIndicated?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
NivolumabOPDIVO, Bristol-Myers Squibb CoIndicated for the treatment of hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib.September 22, 2017
PembrolizumabKEYTRUDA, 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
CabazitaxelJEVTANA, Sanofi-AventisThis 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
CopanlisibALIQOPA, 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
Bevacizumab-awwbMvasi,?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
Gemtuzumab ozogamicinMylotarg, 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
TisagenlecleucelKYMRIAH, 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
Olaparib tabletsLynparza, AstraZenecaIndicated for?the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy.Regular approval.
August 17, 2017
Inotuzumab ozogamicinBESPONSA,, 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
A liposome-encapsulated combination of daunorubicin and cytarabineVYXEOS, 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
IbrutinibImbruvica, Pharmacyclics LLCIndicated for the treatment of adult patients with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy. This is the first FDA-approved therapy for the treatment of cGVHD.August 2, 2017
EnasidenibIDHIFA, 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
NivolumabOPDIVO, Bristol-Myers Squibb CompanyIndicated?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
NeratinibNERLYNX, 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
BlinatumomabBLINCYTO, Amgen IncIndicated?for the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children.July 11, 2017
L-glutamine oral powderEndari, 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
Praxis Extended RAS PanelIllumina, 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
BetrixabanBEVYXXA, PortolaIndicated 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
Dabrafenib and trametinibTAFINLAR 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
Rituximab and hyaluronidase humanRITUXAN HYCELA, Genentech Inc.Indicated for adult patients with follicular lymphoma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia.June 22, 2017
Aminolevulinic acid hydrochloride, known as ALA HClGleolan, NX Development CorpApproved 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
CeritinibZYKADIA, 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
PembrolizumabKEYTRUDA, 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
PembrolizumabKEYTRUDA, 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
PembrolizumabKEYTRUDA, 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
AvelumabBAVENCIO, 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
DurvalumabIMFINZI, AstraZeneca UK LimitedIndicated 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
BrigatinibALUNBRIG 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
MidostaurinRYDAPT, 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
RegorafenibSTIVARGA, 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
Philips IntelliSite Pathology SolutionPIPS, 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
Ipsogen JAK2 RGQ PCR KitQIAGEN GmbHApproved 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
PalbociclibIBRANCE, 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
OsimertinibTAGRISSO, AstraZeneca Pharmaceuticals, LPIndicated 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
NiraparibZEJULA, Tesaro, IncA 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
AvelumabBAVENCIO, 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
PembrolizumabKEYTRUDA, 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
RibociclibKISQALI, 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
LenalidomideRevlimid, Celgene Corp.Indicated as maintenance therapy for patients with multiple myeloma following autologous stem cell transplant.February 22, 2017
NivolumabOPDIVO, Bristol-Myers Squibb CompanyIndicated for 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 a platinum-containing chemotherapy.Accelerated approval.
February 2, 2017

Last Editorial Review: November 23, 2017

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