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FDA Oncologic Drugs Advisory Committee to Review Status of 6 Indications Granted Accelerated Approval

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March 11, 2021

The following quote is attributed to Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research:

“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.

The program allows the FDA to approve a drug or biologic product intended to treat a serious or life-threatening condition based on an outcome that can be measured earlier than survival that demonstrates a meaningful advantage over available therapies. However, when confirmatory trials do not confirm clinical benefit, a reevaluation must be performed to determine if the approval should be withdrawn.

“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.”

Additional Information

  • Today, the U.S. Food and Drug Administration announced that the agency will hold a public meeting of the Oncologic Drugs Advisory Committee on April 27-29 to discuss six indications granted accelerated approval that have since reported results from a confirmatory trial(s) that have not verified clinical benefit. These products are being used under accelerated approval to treat patients with breast, urothelial, gastric and hepatocellular cancers:
    • 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; for treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy (Genentech Inc.).
    • Pembrolizumab: for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy; 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; the treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib (Merck Sharpe & Dohme Corp.).
    • Nivolumab: as a single agent for the treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib (Bristol Myers Squibb).
  • The FDA’s Oncology Center of Excellence requested this meeting as part of an industry-wide evaluation of accelerated approvals in oncology in which confirmatory trials did not confirm clinical benefit.
  • Based on the updates provided at this meeting, the committee will have a general discussion of individual drugs, including the continued approval of the specific indication and if additional trials would be required.
  • Through this industry-wide evaluation, four indications were voluntarily withdrawn (Bristol Myers Squibb, AstraZeneca) or voluntary withdrawal is planned (Merck & Co.; Genentech Inc.) in consultation with the FDA:
    • Nivolumab for the treatment of patients with metastatic small cell lung cancer with progression after platinum-based chemotherapy and at least one other line of therapy (Bristol Myers Squibb);
    • Durvalumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease has progressed during or following platinum-based chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy (AstraZeneca);
    • Pembrolizumab for the treatment of patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy (Merck & Co.);
    • Atezolizumab for treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing atezolizumab chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy (Genentech Inc.).
  • Since the inception of the accelerated approval program, including these four withdrawals, only 6% of accelerated approvals for oncology indications have been withdrawn.

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