FDA to Reevaluate Six Accelerated Approvals of Cancer Treatments

The FDA held a public meeting of its Oncologic Drugs Advisory Committee in late April to reevaluate six treatments that were previously granted accelerated approval and have since reported results that failed to verify clinical benefit.

The FDA’s accelerated approval program is intended to make safe and effective drugs available to patients with unmet medical needs as quickly as possible. “However, when confirmatory trials do not confirm clinical benefit, a reevaluation must be performed to determine if the approval should be withdrawn,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the agency’s Center for Drug Evaluation and Research, in advance of the meeting. “This public meeting of the advisory committee creates an opportunity for external oncology experts and patients with cancer to share input and perspective with the FDA. After this advisory meeting, our staff will consider the committee’s comments and will make final decisions regarding continuing approval of each indication.”

This meeting is part of an industry-wide evaluation of such cases. Since the accelerated approval program was established in 1992, 6% of accelerated approvals for oncology indications have been withdrawn.

The six indications for discussion are:

  • atezolizumab in combination with paclitaxel protein-bound for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer whose tumors express PD-L1
  • atezolizumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy
  • pembrolizumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy
  • pembrolizumab for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy
  • pembrolizumab for the treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib
  • nivolumab as a single agent for the treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib

Source: FDA press release, March 11, 2021.