FDA Oncology New Drug/New Indication Approvals for 2015

As of December 20, 2015


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The following new hematology/oncology agents and expanded indications were approved by the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research in 2015:

  • Alectinib (Alecensa), an ALK inhibitor, for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non–small cell lung cancer (NSCLC) who have had disease progression on or are intolerant to crizotinib (Xalkori). Approved December 11, 2015.
  • Uridine triacetate (Vistogard), for the emergency treatment of adult and pediatric patients following a fluorouracil (5-FU) or capecitabine overdose regardless of the presence of symptoms or who exhibit early-onset, severe, or life-threatening toxicity affecting the cardiac or central nervous system and/or early-onset, unusually severe adverse reactions within 96 hours following the end of 5-FU or capecitabine administration. Approved December 11, 2015.
  • Elotuzumab (Empliciti), a monoclonal antibody, in combination with lenalidomide (Revlimid) and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies. Approved November 30, 2015.
  • Necitumumab (Portrazza), a monoclonal antibody, in combination with gemcitabine and cisplatin for first-line treatment of patients with metastatic squamous NSCLC. Approved November 24, 2015.
  • Nivolumab (Opdivo), a monoclonal antibody, for the treatment of advanced renal cell carcinoma in patients who have received prior antiangiogenic therapy. Approved November 23, 2015.
  • Ixazomib (Ninlaro), a proteasome inhibitor, in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. Approved November 20, 2015.
  • Daratumumab (Darzalex), a monoclonal antibody, administered as a single agent for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, or who are double-refractory to a proteasome inhibitor and an immunomodulatory agent. Approved November 16, 2015.
  • Osimertinib (Tagrisso), a tyrosine kinase inhibitor, for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation–positive NSCLC, as detected by an FDA-approved test, who have had disease progression on or after EGFR tyrosine kinase inhibitor therapy. Approved November 13, 2015.
  • Cobimetinib (Cotellic), a MEK inhibitor, for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutation, in combination with vemurafenib (Zelboraf). Approved November 10, 2015.
  • Ipilimumab (Yervoy), a monoclonal antibody, for the additional indication of adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy. Approved October 28, 2015.
  • Trabectedin (Yondelis), a novel anticancer agent, for the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who have received a prior anthracycline-containing regimen. Approved October 23, 2015.
  • Irinotecan liposome (Onivyde), a liposomal formulation of the topo­isomerase I inhibitor irinotecan, administered in combination with 5-FU and leucovorin, for the treatment of patients with metastatic adenocarcinoma of the pancreas whose disease has progressed following gemcitabine-based therapy. Approved October 22, 2015.
  • Idarucizumab (Praxbind), a monoclonal antibody, for the treatment of patients treated with dabigatran (Pradaxa) when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding. Approved October 16, 2015.
  • Nivolumab (Opdivo), a monoclonal antibody, for the treatment of patients with metastatic NSCLC with disease progression on or after platinum-based chemotherapy. Approved October 9, 2015.
  • Pembrolizumab (Keytruda), a monoclonal antibody, for the treatment of patients with metastatic NSCLC whose tumors express programmed death ligand 1 (PD-L1) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Approved October 2, 2015.
  • Nivolumab (Opdivo), a monoclonal antibody, in combination with ipilimumab for the treatment of patients with BRAF V600 wild-type, unresectable or metastatic melanoma. Approved September 30, 2015.
  • Trifluridine/tipiracil (Lonsurf), a nucleoside analog and thymidine phosphorylase inhibitor, respectively, for the treatment of patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biologic product, and an anti-EGFR monoclonal antibody, if their disease is RAS wild-type. Approved September 22, 2015.
  • Eltrombopag (Promacta), a c-mpl (TpoR) receptor agonist, for the treatment of thrombocytopenia in pediatric patients aged 1 year and older with chronic idiopathic thrombocytopenia who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Approved August 24, 2015.
  • Brentuximab vedotin (Adcetris), an antibody-drug conjugate for the post–autologous hematopoietic stem cell transplantation consolidation treatment of patients with classical Hodgkin lymphoma at high risk of relapse or disease progression. Approved August 17, 2015.
  • Carfilzomib (Kyprolis), a selective proteasome inhibitor, in combination with lenalidomide and dexamethasone for the treatment of patients with relapsed multiple myeloma who have received one to three prior lines of therapy. Approved July 24, 2015.
  • Sonidegib (Odomzo), an oral Hedgehog signaling pathway inhibitor, for the treatment of patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy or those who are not candidates for surgery or radiation therapy. Approved July 24, 2015.
  • Gefitinib (Iressa) for the treatment of patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test. This approval of gefitinib was approved concurrently with a labeling expansion of the therascreen EGFR RGQ PCR Kit, a companion diagnostic test for patient selection. Approved July 13, 2015.
  • Ramucirumab (Cyramza), a monoclonal antibody, for use in combination with FOLFIRI (leucovorin, 5-FU, irinotecan) for the treatment of patients with metastatic colorectal cancer (whose disease has progressed on a first-line bevacizumab (Avastin)-, oxaliplatin-, and fluoropyrimidine-containing regimen. Approved April 24, 2015.
  • Dinutuximab (Unituxin), a monoclonal antibody, in combination with granulocyte-macrophage colony-stimulating factor (Leukine), interleukin-2 (IL-2, Proleukin), and 13-cis-retinoic acid, for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy. Approved March 10, 2015.
  • Filgrastim-sndz (Zarxio), a human granulocyte colony-stimulating factor, as a biosimilar to U.S.-licensed filgrastim (Neupogen) for the five indications for which U.S.-licensed filgrastim is approved. The formulation of Zarxio differs from that of U.S.-licensed filgrastim in one inactive component. Approved March 6, 2015.
  • Nivolumab (Opdivo), a monoclonal antibody, for the treatment of patients with metastatic squamous NSCLC with disease progression on or after platinum-based chemotherapy. Approved March 4, 2015.
  • Panobinostat (Farydak), an oral nonselective histone deacetylase (pan HDAC) inhibitor in combination with bortezomib (Velcade) and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior regimens, including bortezomib and an immunomodulatory agent. As a condition of this accelerated approval, the FDA requires the sponsor to conduct a trial to verify and describe the clinical benefit of panobinostat for patients with multiple myeloma. Approved February 23, 2015.
  • Lenvatinib (Lenvima), a multikinase inhibitor, for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine–refractory differentiated thyroid cancer. Approved February 13, 2015.
  • Palbociclib (Ibrance), a kinase inhibitor, for use in combination with letrozole for the treatment of postmenopausal women with estrogen receptor–positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer as initial endocrine-based therapy for metastatic disease. Approved February 3, 2015.
  • Ibrutinib (Imbruvica), a selective and covalent oral Bruton’s tyrosine kinase inhibitor, for the treatment of patients with Waldenström’s macroglobulinemia. Approved January 29, 2015. ■


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