FDA Will Re-Evaluate Accelerated Approval for Six Cancer Drugs

The Food and Drug Administration (FDA) announced that they will hold a public meeting of the Oncologic Drugs Advisory Committee to discuss six indications for oncology drugs that were granted accelerated approval. Following the approvals, results from confirmatory trials have not verified clinical benefit of these agents.

The meeting will take place from April 27th to 29th, 2021.

The six indications up for discussion are:

  • Atezolizumab, approved in combination with paclitaxel protein-bound for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer whose tumors express PD-L1 expression; and for treatment of adults with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy.
  • Pembrolizumab, for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy; for treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1, with disease progression after ≥2 prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy; and for treatment of patients with hepatocellular carcinoma who were previously treated with sorafenib.
  • Nivolumab, for the treatment of patients with hepatocellular carcinoma who were previously treated with sorafenib.

“We are committed to ensuring the integrity of the accelerated approval program, which is designed to bring safe and effective drugs to patients with unmet medical needs as quickly as possible,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence, via a press release. “When confirmatory trials do not confirm clinical benefit, a reevaluation must be performed to determine if the approval should be withdrawn.”