Two more indications on cancer with “hanging approvals”


Approvals of two more cancer indications that had been granted accelerated approval by the U.S. Food and Drug Administration (FDA) will remain in effect, at least for now. This was the verdict after the second day of a historic three-day meeting (April 27-29) and after similar verdict from day one.

To date, federal advisers have supported the idea of ​​maintaining conditional approvals of some cancer indications for various immunotherapy checkpoint inhibitors, despite poor results in studies that were to confirm the benefit of these drugs. for certain patients.

On the second day (April 28) of the 3-day FDA meeting, the Oncology Drug Advisory Committee (ODAC) supported the views of pharmaceutical companies in two more cases than the staff of the top agencies. they call it “hanging accelerated approvals”.

ODAC voted 10-1 in favor of maintaining the indication of atezolizumab (Tecentriq) for the first-line treatment of ineligible cisplatin patients with advanced / metastatic urothelial carcinoma, pending the final overall survival results of the IMvigor130 trial.

ODAC also voted 5-3 that day in favor of maintaining an accelerated approval for pembrolizumab (Keytruda) for first-line patients not eligible for cisplatin and carboplatin with advanced / metastatic urothelial carcinoma.

The FDA often follows the advice of its panels, but is not required to do so. If the FDA decides to withdraw the indications in question from these PD-1 drugs, these decisions would not remove these drugs from the market. All three drugs have already been approved for other indications about cancer.

Off-label prescribing is not uncommon in oncology, but the loss of an approved indication would affect reimbursement of these drugs, he told ODAC members during Merck & Co’s oncology clinical research (the pembrolizumab manufacturer) Scot Ebbinghaus, MD. a discussion of the possible consequences of removing the indications in question.

“Access to these treatments can end up being substantially limited and the best way to make sure there is access is to maintain FDA approval,” Ebbinghaus said.

Another participant in the meeting asked the group and the FDA to consider the burden on patients of paying for medications that have not yet been shown to be beneficial.

Diana Zuckerman, PhD, of the National Center for Nonprofit Health Research, noted that the ODAC panel included physicians who see cancer patients.

“You’re used to trying different types of treatments in the hopes that something will work,” he said. “Shouldn’t cancer patients be eligible for free treatment in clinical trials instead of paying for treatment that hasn’t been shown to work?”

Rapid development of PD-1 drugs

Senior FDA officials posed the challenges with accelerated approvals of immunotherapeutic drugs in a Article of April 21 inside The New England Journal of Medicine. Over the course of about 6 years, the FDA approved six of these PD-1 or PD-L1 drugs for more than 75 indications in oncology, wrote Richard Pazdur, MD, and Julia A. Beaver, MD, of the FDA.

“Drug development in this class occurred more rapidly than in any other therapeutic area in history,” they wrote.

In 10 cases, the required follow-up trials did not confirm the expected benefit, and yet the marketing authorization for these drugs continued, leading Pazdur and Beaver to doubt these accelerated “hanging” approvals. Four of these indications were voluntarily retired. For the other six indications, the FDA requested comments from ODAC during the three-day meeting. During the first two days of the meeting, ODAC recommended that three of these indications about cancer be maintained. Three more will be considered on the last day of the meeting.

Kerry Dooley Young is a freelance journalist based in Washington, DC. Previously, he covered health policy and the federal budget for the convening of the Quarterly Congress / QC and the Pharmaceutical and Food and Drug Administration for Bloomberg. Follow her on Twitter at @kdooleyyoung.

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