Articles

New York, NY—With cancer drugs representing some of the most expensive pharmaceuticals on the market, conversations abound around value in oncology and proposed solutions for achieving it. At the 2019 AVBCC Summit, experts on the topic of drug pricing hashed out which frameworks are best suited for real-world applications in cancer care.

On December 12, 2019, the FDA issued draft guidance to implement amendments to the Federal Food, Drug, and Cosmetic (FD&C) Act that will facilitate early assessment of studies of molecularly targeted oncology drugs that may be effective in the treatment of pediatric cancers.

On December 3, 2019, the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to the biopharmaceutical company Adaptimmune Therapeutics for ADP-A2M4 for the treatment of synovial sarcoma. Earlier this year, the FDA granted Orphan Drug Designation to the agent for the treatment of soft tissue sarcomas.

On December 2, 2019, Merck announced that the FDA has granted priority review for its supplemental biologics license application for the anti–PD-1 agent pembrolizumab (Keytruda).

Medicare models for value-based care in oncology started with the Oncology Care Model (OCM), which was launched in July 2016 and will run until June 2021.

On November 15, 2019, the FDA approved crizanlizumab (Adakveo; Novartis) to reduce the frequency of vaso-occlusive crises (VOCs) in adults and pediatric patients aged ≥16 years with sickle-cell disease.