FDA Oncology Drug Approvals Granted Between June 2017 and May 16, 2018


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Over the past year (June 2017–May 2018), the U.S. Food and Drug Administration (FDA) granted approval to a number of new oncology drug products, including several biosimilar products. Here we provide the labeling approved for these novel drugs and new indications. 

EPOETIN ALFA-EPBX (RETACRIT) received approval from the FDA as a biosimilar to epoetin alfa (Epogen, Procrit) for the treatment of anemia due to chronic kidney disease 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. May 15, 2018. 

DABRAFENIB (TAFINLAR) PLUS TRAMETINIB (MEKINIST) in combination for anaplastic thyroid cancer with BRAF V600E mutation. May 4, 2018. 

TISAGENLECLEUCEL (KYMRIAH), 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. May 1, 2018. 

DABRAFENIB (TAFINLAR) AND TRAMETINIB (MEKINIST), 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. April 30, 2018. 

OSIMERTINIB (TAGRISSO), 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. April 19, 2018. 

FOSTAMATINIB DISODIUM HEXAHYDRATE TABLETS (TAVALISSE) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. April 17, 2018. 

NIVOLUMAB (OPDIVO) AND IPILIMUMAB (YERVOY) in combination for the treatment of intermediate- or poor-risk, previously untreated advanced renal cell carcinoma. April 16, 2018. 

EVEROLIMUS TABLETS FOR ORAL SUSPENSION (AFINITOR DISPERZ) 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 and TSC-associated renal angiomyolipoma. April 10, 2018. 

RUCAPARIB (RUBRACA) for maintenance treatment of recurrent ovarian, fallopian tube, or primary peritoneal cancer. April 6, 2018. 

BLINATUMOMAB (BLINCYTO) 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 greater than or equal to 0.1%. March 29, 2018. 

NILOTINIB (TASIGNA) 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 therapy. March 22, 2018. 

BRENTUXIMAB VEDOTIN (ADCETRIS) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma in combination with chemotherapy. March 20, 2018. 

ABEMACICLIB (VERZENIO) in combination with an aromatase inhibitor as initial endocrine-based therapy for postmenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer. February 26, 2018. 

DURVALUMAB (IMFINZI) for patients with unresectable stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. February 16, 2018. 

APALUTAMIDE (ERLEADA) for nonmetastatic castration-resistant prostate cancer. February 14, 2018. 

ABIRATERONE ACETATE (ZYTIGA) tablets in combination with prednisone for metastatic high-risk castration-sensitive prostate cancer. February 7, 2018. 

LUTETIUM LU 177 DOTATATE (LUTATHERA), a radiolabeled somatostatin analog, for the treatment of somatostatin receptor–positive gastroenteropancreatic neuroendocrine tumors, including foregut, midgut, and hindgut neuroendocrine tumors in adults. January 26, 2018. 

AFATINIB (GILOTRIF) for a broadened indication in first-line treatment of patients with metastatic NSCLC whose tumors have nonresistant EGFR mutations as detected by an FDA-approved test. January 12, 2018. 

OLAPARIB (LYNPARZA) a poly (ADP-ribose) polymerase (PARP) inhibitor, for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated, HER2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting. January 12, 2018. 

NILOTINIB (TASIGNA), product labeling updated to include information on nilotinib discontinuation, postdiscontinuation monitoring criteria, and guidance for treatment re-initiation in patients taking nilotinib for Ph+ CML who have achieved a sustained molecular response (MR 4.5). December 22, 2017. 

HYDROXYUREA (SIKLOS) to reduce the frequency of painful crises and the need for blood transfusions in pediatric patients from 2 years of age and older with sickle cell anemia with recurrent moderate to severe painful crises. December 21, 2017. 

PERTUZUMAB (PERJETA) for use in combination with trastuzumab and chemotherapy as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence. December 20, 2017. 

NIVOLUMAB (OPDIVO), an anti–PD-1 monoclonal antibody, for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or in patients with metastatic disease who have undergone complete resection. Nivolumab was previously approved for the treatment of patients with unresectable or metastatic melanoma. December 20, 2017. 

BOSUTINIB (BOSULIF) for treatment of patients with newly diagnosed chronic-phase Ph+ CML. December 19, 2017. 

CABOZANTINIB (CABOMETYX) for treatment of patients with advanced renal cell carcinoma. December 19, 2017. 

TRASTUZUMAB-DKST (OGIVRI) as a biosimilar to trastuzumab (Herceptin) for the treatment of patients with HER2-overexpressing breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma). December 1, 2017. 

A NEXT-GENERATION SEQUENCING–BASED IN VITRO DIAGNOSTIC, FOUNDATIONONE CDX (F1CDX), was approved to detect genetic mutations in 324 genes and two genomic signatures in any solid tumor type. November 30, 2017. 

SUNITINIB MALATE (SUTENT) for the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma following nephrectomy. November 16, 2017. 

OBINUTUZUMAB (GAZYVA) 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. November 16, 2017. 

EMICIZUMAB-KXWH (HEMLIBRA) 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.

DASATINIB (SPRYCEL) for the treatment of pediatric patients with Ph+ CML in chronic phase. November 9, 2017. 

BRENTUXIMAB VEDOTIN (ADCETRIS) for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma or CD30-expressing mycosis fungoides who have received prior systemic therapy. November 9, 2017. 

ALECTINIB (ALECENSA) for treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic NSCLC, as detected by an FDA-approved test. November 6, 2017. 

VEMURAFENIB (ZELBORAF) for the treatment of patients with Erdheim-Chester disease with BRAF V600 mutation. November 6, 2017. 

ACALABRUTINIB (CALQUENCE) for treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy. October 31, 2017. 

AXICABTAGENE CILOLEUCEL (YESCARTA) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. October 18, 2017. 

ABEMACICLIB (VERZENIO) in combination with fulvestrant for women with hormone receptor– positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy. September 28, 2017. 

NIVOLUMAB (OPDIVO; accelerated approval) for the treatment of hepatocellular carcinoma in patients who have been previously treated with sorafenib. September 22, 2017. 

PEMBROLIZUMAB (KEYTRUDA) 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. 

CABAZITAXEL AT A LOWER DOSE OF 20 MG/M2 EVERY 3 WEEKS (JEVTANA) 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. 

COPANLISIB (ALIQOPA) for the treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies. September 14, 2017. 

BEVACIZUMAB-AWWB (MVASI), a biosimilar to bevacizumab (Avastin). September 14, 2017. 

GEMTUZUMAB OZOGAMICIN (MYLOTARG) 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. 

TISAGENLECLEUCEL (KYMRIAH) for the treatment of patients up to age 25 years with B-cell precursor ALL that is refractory or in second or later relapse. August 30, 2017.

OLAPARIB TABLETS (LYNPARZA) 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. August 17, 2017. 

INOTUZUMAB OZOGAMICIN (BESPONSA) for the treatment of adults with relapsed or refractory B-cell precursor ALL. August 17, 2017. 

A LIPOSOME-ENCAPSULATED COMBINATION OF DAUNORUBICIN AND CYTARABINE (VYXEOS) for the treatment of adults with newly diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes—two types of AML with a poor prognosis. August 3, 2017. 

IBRUTINIB (IMBRUVICA) for the treatment of adult patients with chronic graft-versus-host disease (GVHD) after failure of one or more lines of systemic therapy. This is the first FDA-approved therapy for the treatment of chronic GVHD. August 2, 2017. 

ENASIDENIB (IDHIFA) for the treatment of adult patients with relapsed or refractory AML with an IDH2 mutation as detected by an FDA-approved test. August 1, 2017. 

NIVOLUMAB (OPDIVO; accelerated approval) for the treatment of patients 12 years and older with mismatch repair–deficient and microsatellite instability–high (MSI-H) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. August 1, 2017. 

NERATINIB (NERLYNX) 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. 

BLINATUMOMAB (BLINCYTO) for the treatment of relapsed or refractory B-cell precursor ALL in adults and children. July 11, 2017. 

L-GLUTAMINE ORAL POWDER (ENDARI) for oral administration to reduce the acute complications of sickle cell disease in adult and pediatric patients 5 years and older. July 7, 2012. 

A NEXT-GENERATION SEQUENCING TEST (PRAXIS EXTENDED RAS PANEL), to detect certain genetic mutations in RAS genes in tumor samples of patients with metastatic colorectal cancer. The test is used to aid in the identification of patients who may be eligible for treatment with panitumumab (Vectibix). June 29, 2017. 

BETRIXABAN (BEVYXXA) 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 (TAFINLAR) AND TRAMETINIB (MEKINIST; regular approval) administered in combination for patients with metastatic NSCLC with BRAF V600E mutation as detected by an FDA-approved test. June 22, 2017. 

RITUXIMAB AND HYALURONIDASE HUMAN (RITUXAN HYCELA) combination for adult patients with follicular lymphoma, DLBCL, and chronic lymphocytic leukemia. June 22, 2017. 

AMINOLEVULINIC ACID HYDROCHLORIDE, KNOWN AS ALA HCL (GLEOLAN) 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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