FDA Drug Approvals for Cancer in 2015

On February 3, 2015, the FDA granted accelerated approval to palbociclib (Ibrance) for use in combination with letrozole for the treatment of postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer as initial endocrine-based therapy for their metastatic disease. Image (left) © molekuul.be / Shutterstock.com

On February 13, 2015, the FDA approved lenvatinib (Lenvima) for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer. Images © molekuul.be (left), Sebastian Kaulitzki (right) / Shutterstock.com

On February 23, 2015, the FDA granted accelerated approval to panobinostat (Farydak) in combination with bortezomib and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior regimens, including bortezomib and an immunomodulatory agent. Image (left) © molekuul.be / Shutterstock.com; image (right) © KGH

On March 4, 2015, the FDA granted approval to nivolumab (Opdivo) for the treatment of patients with metastatic squamous non–small-cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Image (left) Bristol-Myers Squibb; image (right) © muratart / Shutterstock.com

On April 24, 2015, the FDA approved approved ramucirumab (Cyramza) for use in combination with FOLFIRI for the treatment of patients with metastatic colorectal cancer whose disease has progressed on a first line bevacizumab-, oxaliplatin-, and fluoropyrimidine-containing regimen. Ramucirumab is a recombinant human monoclonal IgG1 antibody that binds to the human vascular endothelial growth factor- receptor 2 (VEGFR2), preventing the interaction of VEGFR2 to its ligands. Image (left) © Eli Lilly; image (right) © Sebastian Kaulitzki / Shutterstock.com

On July 13, 2015, the FDA approved gefitinib (Iressa) for the treatment of patients with metastatic NSCLC whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test. This approval of gefitinib is being approved concurrently with a labeling expansion of the therascreen EGFR RGQ PCR Kit, a companion diagnostic test for patient selection. Image (left) © molekuul.be / Shutterstock.com; image (right) by Kelly Nelson

On July 24, 2015, the FDA approved sonidegib (Odomzo Capsules, Novartis Pharmaceuticals Corporation) 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. Image (left) © molekuul.be / Shutterstock.com

On July 24, 2015, the FDA approved carfilzomib (Kyprolis) 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. Image (left) © molekuul.be / Shutterstock.com; image (right) © KGH

On August 17, 2015, the FDA approved brentuximab vedotin (Adcetris) for the post-autologous hematopoietic stem cell transplantation consolidation treatment of patients with classical Hodgkin lymphoma at high risk of relapse or progression. Image (left) © molekuul.be / Shutterstock.com

On August 24, 2015, the FDA approved eltrombopag (Promacta for oral suspension) for the treatment of thrombocytopenia in pediatric patients 1 year and older with idiopathic thrombocytopenia who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Image © molekuul.be

On September 22, 2015, the FDA approved trifluridine/tipiracil (Lonsurf) 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 RAS wild-type. Images © molekuul.be (left), Sebastian Kaulitzki (right) / Shutterstock.com

On September 30, 2015, the FDA granted accelerated approval to nivolumab (Opdivo) in combination with ipilimumab for the treatment of patients with BRAF V600 wild-type, unresectable or metastatic melanoma. Image (left) courtesy of Bristol-Myers Squibb; image (right) by Larry Meyer

On October 2, 2015, the FDA granted accelerated approval to pembrolizumab (Keytruda) 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. Image (left) copyright © 2009–2015 Merck

On October 9, 2015, the FDA approved nivolumab (Opdivo), for the treatment of patients with metastatic NSCLC with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving nivolumab. Image (left) courtesy of Bristol-Myers Squibb

On October 22, 2015, the FDA approved irinotecan liposome injection (Onivyde), administered in combination with fluorouracil and leucovorin, for the treatment of patients with metastatic adenocarcinoma of the pancreas whose disease has progressed following gemcitabine-based therapy. Image (right) © Sebastian Kaulitzki / Shutterstock.com

On October 23, 2015, the FDA approved trabectedin (Yondelis) for the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who have received a prior anthracycline-containing regimen. Photo courtesy of Janssen.

On October 28, 2015, the FDA approved ipilimumab (Yervoy), 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. Image courtesy of Bristol-Myers Squibb

On November 10, 2015, the FDA approved cobimetinib (Cotellic) for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutation, in combination with vemurafenib. Cobimetinib is not indicated for treatment of patients with wild-type BRAF melanoma. Images © molekuul.be (left), Juan Gaertner (right) / Shutterstock.com

On November 13, 2015, the FDA granted accelerated approval to osimertinib (Tagrisso) once daily tablets 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 progressed on or after EGFR tyrosine kinase inhibitor therapy.

On November 16, 2015, based on results of the phase II MMY2002 (SIRIUS) trial the FDA granted accelerated approval to daratumumab injection (Darzalex), 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. Photo courtesy of Janssen.

On November 20, 2015, the FDA approved trametinib (Mekinist) and dabrafenib (Tafinlar) for use in combination for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. Image (right) courtesy of the National Cancer Institute

On November 20, 2015, the FDA approved ixazomib (Ninlaro) in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. Ixazomib is the first approved oral proteasome inhibitor. Image (left) © molekuul.be / Shutterstock.com; image (right) courtesy of the National Cancer Institute

On November 23, 2015, the FDA approved nivolumab (Opdivo) for the treatment of advanced renal cell carcinoma in patients who have received prior anti-angiogenic therapy. Image (left) courtesy of Bristol-Myers Squibb; image (right) © Sebastian Kaulitzki / Shutterstock.com

On November 30, 2015, the FDA approved elotuzumab (Empliciti) in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies. Image (left) courtesy of Bristol-Myers Squibb; image (right) by Erhabor Osaro

On December 11, 2015, the FDA granted accelerated approval to alectinib (Alecensa) capsules for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic NSCLC who have progressed on or are intolerant to crizotinib. Image (right) copyright © Sebastian Kaulitzki / Shutterstock.com

On December 18, 2015 the FDA expanded the approval of pembrolizumab (Keytruda) for patients with melanoma. The expanded indication now includes the initial treatment of patients with unresectable or metastatic melanoma. Image (left) copyright © 2009–2015 Merck; image (right) copyright © Australis Photography / Shutterstock.com (right)