A Good Year: FDA Approved Nine New Cancer Drugs in 2014
, by NCI Staff
In 2014, the Food and Drug Administration (FDA) approved 41 drugs that had not been approved previously for any indication, the most in nearly 20 years. Of these 41 novel drugs, 9 were approved for the treatment of cancer or cancer-related conditions.
The development of new therapeutic biologics, in particular, is a trend that continues to drive cancer drug development and approval by the FDA, according to Henry Francis, M.D., of the FDA’s Center for Drug Evaluation and Research.
The FDA’s acceleration of the review process for cancer drug approval is another important factor, added Dr. Francis. Because treatment options are limited for many cancer patients with advanced disease, the FDA has implemented expedited approval procedures for cancer drugs. In some respects, the approach resembles how the agency evaluated and approved early AIDS drugs, he noted.
The following are the new drugs for cancer or cancer-related conditions approved last year by the FDA:
- Belinostat (Beleodaq) to treat relapsed or refractory peripheral T-cell lymphoma, approved July 2014
- Blinatumomab (Blincyto) to treat Philadelphia chromosome-negative relapsed/refractory B-cell precursor acute lymphoblastic leukemia, approved December 2014
- Ceritinib (Zykadia) to treat ALK-positive metastatic non-small cell lung cancer, approved April 2014
- Idelalisib (Zydelig) to treat relapsed chronic lymphocytic leukemia (CLL), follicular B-cell non-Hodgkin lymphoma, and small lymphocytic lymphoma, approved July 2014
- Netupitant and palonosetron (Akynzeo) a combination pill to prevent chemotherapy-induced nausea and vomiting, approved October 2014
- Nivolumab (Opdivo) to treat unresectable or metastatic melanoma, approved December 2014
- Olaparib (Lynparza) to treat previously treated BRCA-mutated advanced ovarian cancer, approved December 2014
- Pembrolizumab (Keytruda) to treat unresectable or metastatic melanoma, approved September 2014
- Ramucirumab (Cyramza) to treat gastric (stomach) cancer, approved April 2014
In February 2014, the FDA also gave full approval for ibrutinib (Imbruvica) to treat CLL. It was initially given accelerated approval in 2013 for patients with mantle cell lymphoma, a rare and aggressive type of blood cancer.