2014 was a busy year for the US Food and Drug Administration (FDA). 41 brand new drugs were approved, and 9 of them were for cancer, according to the US National Cancer Institute (NCI). This is the highest number of new drugs approved in 20 years.
Many of the new drugs approved are biologics, derived from living organisms rather than chemicals. Biologics tend to include monoclonal antibodies, whole cells, or recombinant DNA products. The FDA researcher Henry Francis, M.D., reports that biologics are “a trend that continues to drive cancer drug development and approval by the FDA.” Over half of 2014’s new cancer drugs are monoclonal antibodies. Many new immunotherapies derived from living material are expected to be approved in the next few years.
The acceleration in the development of biologics has generally been good news for cancer patients, especially since biotech companies tend “to target more difficult-to-treat populations that would be too small for pharmaceutical companies to be able to recoup drug-development costs”, according to a report by Thomas Morrow, M.D. Many cancers fall into the category of “orphan diseases”, an official FDA designation for conditions whose annual population is not big enough to attract pharmaceutical development.
Unfortunately, biologics tend to be very expensive to produce and administer, as many patients discovered in the early days of the monoclonal antibody Avastin. And as with Avastin, Morrow believes that while “most of today’s blockbuster drugs are chemically derived, the next generation of blockbusters could be biologics.”
The 9 new drugs approved by the FDA in 2014 are:
- 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
One of the most recently approved treatments on this list is Amgen’s Blincyto, a first-of-its-kind immunotherapy treatment approved just last month. It’s a bispecific antibody whose Y-shaped protein directly recruits T cells to contact tumor cells. It’s a very powerful weapon against cancer, even cancers which prove refractory to other treatments. Currently, Blincyto is only indicated for acute lymphoblastic leukemia (ALL), a cancer of the blood and bone marrow which is the most common type of cancer in children. In its final study, Blincyto delivered a complete response (complete remission) in 32% of the patients. However such a powerful immune response comes with the challenge of over-stimulating the immune system to attack healthy tissue. A story published today by Fox News reported that “at least 30 bispecific antibodies are believed to be in development” from various drug makers.