NEW FDA APPROVALS IN ONCOLOGY: 2020 HIGHLIGHTS

 
  • 20 novel drugs from 19 different companies were approved for 15 different conditions.
  • In addition, 2 approvals were for new formulations of already marketed drugs—Onureg® (azacytidine) and Darzalex FasproTM (daratumumab and hyaluronidase-fihj).
  • For the first time ever, more than half of the approvals (11) were “accelerated” (i.e., based on intermediate endpoints). Continued approval for these drugs may depend on verification of clinical benefit.
  • Tyrosine kinase inhibitors constituted the largest single drug “type” (there were 7), while drug conjugates were the 2nd largest modality (4).
  • Approvals were about evenly divided between oral and infused/injected agents (9 and 11, respectively).
  • Seven of the approvals specify genetic alterations that should be incorporated into patient selection.
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