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FDA advisory committee to review oncology accelerated approvals

Review comes after voluntary indication withdrawals for a number of cancer therapies

The US Food and Drug Administration (FDA) will convene an advisory committee meeting to discuss six oncology indications with accelerated approvals, amid a major review of cancer drugs that have failed to meet post-marketing requirements. 

The Oncology Drugs Advisory Committee will meet to review six indications for Roche’s Tecentriq (atezolizumab), Merck and Co’s Keytruda (pembrolizumab) and Bristol Myers Squibb’s (BMS) Opdivo (nivolumab) in breast, urothelial, gastric and hepatocellular cancers.

The review comes after a number of drugmakers decided to voluntarily withdraw indications for their respective therapies after post-marketing studies failed to demonstrate continued clinical benefit following initial accelerated approvals.

This includes Merck & Co – known as MSD outside the US and Canada – which withdrew the US indication for Keytruda in metastatic small cell lung cancer (SCLC) last week.

The FDA granted Keytruda an accelerated approval as a third-line treatment for SCLC in June 2019, based on objective response rate (ORR) data in the KEYNOTE-158 and KEYNOTE-028 trials.

However, continued approval in this indication was dependent on a post-marketing study demonstrating the superiority of Keytruda as determined by overall survival (OS).

Keytruda failed to meet this requirement in the KEYNOTE-604 trial, as announced in January 2020.

AZ also recently announced that it would withdraw Imfinzi’s indication for advanced bladder cancer after a post-marketing study failed to hit the mark.

Similarly, BMS decided to withdraw the US indication for PD-1 inhibitor Opdivo (nivolumab) in SCLC which has progressed following prior therapies.

As with Keytruda, Opdivo was granted an accelerated approval in this indication but subsequent confirmatory studies failed to meet their primary endpoints of OS in SCLC.

Finally, Roche announced this week that it would withdraw Tecenriq’s indication in prior-platinum treated metastatic urothelial carcinoma (bladder cancer).

After scoring accelerated approval in this indication, Tecentriq had to achieve continued positive results in bladder cancer as part of the post-marketing requirements set out by the FDA to confirm the immunotherapy’s clinical benefit.

Tecentriq failed to improve overall survival in bladder cancer patients with high levels of PD-L1 expression, however.

The FDA advisory committee will review the additional indications for the three cancer drugs, and make recommendations based on the discussions of all available data.

Although the FDA is not required to follow the recommendations made by the advisory committee as part of this review, it usually does so.

Article by
Lucy Parsons

12th March 2021

From: Regulatory



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