The Oncologic Drugs Advisory Committee Votes of April 2021—Implications for the Fate of Accelerated Approval

Since 2015, the US Food and Drug Administration (FDA) has granted 35 accelerated approvals to programmed cell death 1 (PD-1) and/or PD-1 ligand 1 (PD-L1) inhibitors, or just under half of the total (76) approvals for this class of medications.¹ Of the 35 approvals, 10 were considered “dangling,” with postmarketing trials failing to meet key end points to confirm benefit for patients.² Four of these 10 indications were withdrawn voluntarily by the pharmaceutical sponsors, leaving 6 for review by the FDA’s Oncologic Drugs Advisory Committee (ODAC).¹ The ODAC voted on April 27 to 29, 2021, to keep 4 of the 6 remaining indications on the market.