FDA Approvals, News & Updates

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).

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.

The past week in oncology-related news includes shortages of crucial pediatric cancer drug, results of a study of racial disparities in multiple myeloma, and new drug on the horizon for HER2 metastatic breast cancer.

FDA issues finalized guidelines for use of in vitro diagnostics in oncology drug trials and warnings on vaping; new findings report patients bear more costs when MBC treatment is not concordant with NCCN guidelines.