New FDA Approved drugs for treatment of Cancer (2015)

In the verge of getting treatment and cure for different types of Cancer. The US Food and Drug Administration (FDA) has fully approved these cancer drugs in 2015.

This page also lists common drug combinations used in these cancer types. The individual drugs in the combinations are FDA-approved. However, drug combinations themselves usually are not approved, but are widely used.

• FDA granted accelerated approval to alectinib (ALECENSA capsules, Hoffmann-La Roche Inc.) for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.  More Information.  December 11, 2015

• FDA granted approval to uridine triacetate (VISTOGARD granules, Wellstat Therapeutics Corporation) for the emergency treatment of adult and pediatric patients: 
  • following a fluorouracil 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 (e.g., gastrointestinal toxicity and/or neutropenia) within 96 hours following the end of fluorouracil or capecitabine administration.  More Information.  December 11, 2015
   
• FDA approved elotuzumab (EMPLICITI, Bristol-Myers Squibb Company) in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies.  More Information.  November 30, 2015

• FDA granted approval to necitumumab (PORTRAZZA, Eli Lilly and Company) in combination with gemcitabine and cisplatin for first-line treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC). Necitumumab is not indicated for treatment of non-squamous NSCLC. More Information.  November 24, 2015

• FDA approved nivolumab (Opdivo Injection, Bristol-Myers Squibb Company) for the treatment of advanced renal cell carcinoma in patients who have received prior anti-angiogenic therapy.   More Information.  November 23, 2015

• FDA approved trametinib (Mekinist, Novartis Pharmaceuticals Corp.) and dabrafenib (Tafinlar, Novartis Pharmaceuticals Corp.) 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. More Information.  November 20, 2015.

• FDA approved ixazomib (NINLARO, Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited) 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. More Information.  November 20, 2015

• FDA granted accelerated approval to daratumumab injection (DARZALEX, Janssen Biotech, Inc.), 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 (PI) and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent. More Information.  November 16, 2015

FDA granted accelerated approval to osimertinib (TAGRISSO)  once daily tablets, AstraZeneca Pharmaceuticals LP, 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, who have progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy. More Information.  November 13, 2015

• FDA  approved cobimetinib (COTELLIC Tablets, Genentech, Inc.) 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. More Information.  November 10, 2015

• FDA approved ipilimumab (Yervoy  Injection), 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. More Information.  October 28, 2015

• FDA  approved talimogene laherparepvec (IMLYGIC , Amgen, Inc.), a genetically-modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery. More Information.  October 27, 2015

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

• FDA approved irinotecan liposome injection (ONIVYDE, Merrimack Pharmaceuticals, Inc.), administered in combination with fluorouracil (5FU) and leucovorin (LV), for the treatment of patients with metastatic adenocarcinoma of the pancreas whose disease has progressed following gemcitabine-based therapy.  More Information.  October 22, 2015
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• FDA granted accelerated approval to idarucizumab (Praxbind Injection, Boehringer Ingelheim Pharmaceuticals, Inc.) 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. More Information.  October 16, 2015
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• FDA approved nivolumab (Opdivo  Injection, Bristol-Myers Squibb Company), for the treatment of patients with metastatic non-small cell lung cancer (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 Opdivo.   More Information.  October 9, 2015

• FDA granted accelerated approval to pembrolizumab (KEYTRUDA Injection, Merck Sharp and Dohme Corporation) for the treatment of patients with metastatic non-small cell lung cancer (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.  More Information.  October 2, 2015 

• FDA granted accelerated approval to nivolumab (Opdivo Injection, Bristol-Myers Squibb Company) in combination with ipilimumab for the treatment of patients with BRAF V600 wild-type, unresectable or metastatic melanoma. More Information.  September 30, 2015
• FDA approved trifluridine/tipiracil (LONSURF, Taiho Oncology, Inc.) 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. More Information.  September 22, 2015
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• FDA approved eltrombopag (Promacta for oral suspension, Novartis) for the treatment of thrombocytopenia in pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. More Information.  August 24, 2015 
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• FDA approved brentuximab vedotin (ADCETRIS) for the post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation treatment of patients with classical Hodgkin lymphoma (HL) at high risk of relapse or progression.  More Information.  August 17, 2015

• FDA approved carfilzomib (Kyprolis, Onyx Pharmaceuticals, Inc., an Amgen subsidiary) 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. More Information.  July 24, 2015

• FDA approved sonidegib (Odomzo Capsules, Novartis Pharmaceuticals Corporation) for the treatment of patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy. More Information.  July 24, 2015
• FDA approved gefitinib (IRESSA) for the 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) 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.  More Information.  July 13, 2015

• FDA approved approved ramucirumab (CYRAMZA, Eli Lilly and Company) for use in combination with FOLFIRI for the treatment of patients with metastatic colorectal cancer (mCRC) 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 (VEGF-R2), preventing the interaction of VEGF-R2 to its ligands.  More Information.  April 24, 2015 

• FDA approved dinutuximab (Unituxin, United Therapeutics Corporation), in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy.More Information.  March 10, 2015

• FDA approved filgrastim-sndz (ZARXIO Injection, Sandoz Inc.), as a biosimilar to US-licensed Neupogen for the five indications for which US-licensed Neupogen is approved. The formulation of ZARXIO differs from that of US-licensed Neupogen in one inactive component.  More Information.  March 6, 2015 

• FDA granted approval to nivolumab (OPDIVO, Bristol-Myers Squibb Company) for the treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.  More Information.  March 4, 2015

• FDA granted accelerated approval to panobinostat (FARYDAK capsules, Novartis Pharmaceuticals) 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. As a condition of this accelerated approval, FDA requires the sponsor to conduct a trial to verify and describe the clinical benefit of panobinostat for patients with multiple myeloma. More Information.  February 23, 2015

• FDA approved lenvatinib (Lenvima) for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer.
  More Information. February 13, 2015
  
• FDA granted accelerated approval to palbociclib (IBRANCE, Pfizer, Inc.) 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. More Information.  February 3, 2015  

• FDA approved ibrutinib (Imbruvica Capsules, Pharmacyclics, Inc.) for the treatment of patients with Waldenstrom’s macroglobulinemia (WM).  Ibrutinib was initially approved in November 2013 for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.  Ibrutinib also received approval in February 2014 for the treatment of chronic lymphocytic leukemia (CLL) in patients who received at least one prior therapy and in July 2014 for the treatment of CLL with 17p deletion.  More Information.  January 29, 2015

 SOURCE:

FDA