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FDA sets meeting to review 6 speedy cancer drug approvals as evaluation widens

Dive Brief:

  • The Food and Drug Administration has scheduled a three-day virtual meeting in April to review six accelerated approvals given to cancer immunotherapies from Roche, Bristol Myers Squibb and Merck & Co.


  • At the advisory panel, set for April 27 through 29, regulators, oncologists and patient advocates will discuss what the FDA should do about the six approvals. The drugs were cleared based on early results showing they kept tumors from spreading, but their developers haven’t confirmed those benefits in subsequent trials as the regulator requires.


  • Over the three days, the FDA will listen to status updates from each drug developer and ask panelists whether the medicines should stay on the market for the cancer types in question. They’ll also discuss what additional testing is necessary and if the drugs should be withdrawn while those trials are underway.

Dive Insight:

The meeting marks the most significant step yet in an effort by the FDA to re-evaluate speedy approvals given to cancer drugs in recent years.

These so-called accelerated approvals are granted as part of a pathway the FDA created to clear medicines for serious diseases more quickly than they would be otherwise. They’re given based on the impact drugs have on a “surrogate” marker thought to predict a real benefit such as a longer life. But they’re meant to be conditional, and withdrawn if developers can’t confirm those benefits in further testing.

Since the accelerated approval pathway was first enacted in 1992, drug withdrawals have been the exception rather than the rule. A Thursday statement from the FDA’s oncology division noted how, in the roughly 30-year history of the program, just 6% of speedy approvals for cancer drugs have been pulled.

That’s despite the fact that a 2019 study found about a third of post-marketing trials between 1992 and 2008 weren’t finished, and roughly half of them took at least five years to begin. Some immunotherapy approvals have stood for multiple years even though their confirmatory studies failed.

But that track record may be changing. Four of the withdrawals the FDA used in its 6% figure have come since December, a clear signal the agency is taking a tougher stance. Over that time, Merck, Bristol, AstraZeneca and, most recently, Roche each voluntarily withdrew their top immunotherapies in certain cancer types. All of the companies cited an “industry-wide evaluation” by the FDA in their decision.

Now the FDA’s cancer drug division is bringing the whole process under public scrutiny. Next month, the agency will hear presentations from Roche, Merck and Bristol regarding their respective immunotherapies: Tecentriq, Keytruda and Opdivo. Each will discuss the status of their efforts to confirm existing approvals in cancers of the breast, bladder, stomach and liver. Those presentations lead to a discussion among FDA advisors and input from patients and advocates.

“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, the director of the FDA’s oncology unit, in a statement. “When confirmatory trials do not confirm clinical benefit, a reevaluation must be performed to determine if the approval should be withdrawn.”