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A group of advisers to the Food and Drug Administration this week recommended the agency maintain four of six recent cancer immunotherapy approvals despite a lack of evidence the medicines help patients live longer.
The positive votes, which took place over an unusual three-day meeting, could push the FDA to keep drugs from Roche, Bristol Myers Squibb and Merck & Co. on the market while the companies complete additional studies to confirm their benefit. The FDA typically, though not always, follows the advice of its advisory committees.
If the FDA does adhere to the panel votes, regulators could fuel further criticism that the agency isn t holding drugmakers to the terms of the accelerated approval pathway it s used to make new cancer drugs available quickly.
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A pair of PD-1 immunotherapies used in advanced hepatocellular carcinoma (HCC) met sharply different receptions from FDA advisers reviewing accelerated approvals that failed to show benefit in confirmatory trials.
In considering the two agents for previously treated HCC, the Oncologic Drugs Advisory Committee (ODAC) on Thursday unanimously recommended that FDA maintain its accelerated approval of pembrolizumab (Keytruda), by a vote of 8-0, but split over nivolumab (Opdivo), with a 5-4 vote in favor of revoking the indication.
The divided decision largely stemmed from whether ongoing trials would offer new evidence to support the indications. ODAC members took a wait-and-see approach with pembrolizumab given the imminent readout of KEYNOTE-394, a placebo-controlled second-line trial being conducted in Asia. But with nivolumab, they remained unconvinced that any ongoing trial from drugmaker Bristol Myers Squibb (BMS) would adequately provide insight for the c
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In separate votes, an FDA advisory committee recommended that pembrolizumab (Keytruda) and atezolizumab (Tecentriq) hold on to accelerated approval as first-line therapy for advanced bladder cancer, pending additional clinical trial data.
The Oncologic Drugs Advisory Committee (ODAC) voted 5-3 in favor of Merck maintaining accelerated approval status for pembrolizumab as initial treatment for patients with platinum-ineligible (cisplatin and carboplatin) advanced/metastatic urothelial cancer.
By a 10-1 vote the panel favored continuation of accelerated approval for Genentech s atezolizumab for the same indication. The FDA is not bound by advisory committee decisions but usually follows the committees recommendations.
Despite the disparity in the two votes, panelists indicated that neither decision came easily, as confirmatory trials required for final approval turned out negative or have yet to be completed.
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An advisory panel recommended the FDA not revoke the accelerated approval for atezolizumab (Tecentriq) in combination with nab-paclitaxel (Abraxane) for treating metastatic, PD-L1-positive triple-negative breast cancer (TNBC).
In a 7-2 vote, the Oncologic Drugs Advisory Committee (ODAC) affirmed the accelerated approval, with members clearly conflicted over the decision. This was a difficult decision in a very difficult disease to treat, said Harold Burstein, MD, PhD, of the Dana-Farber Cancer Institute in Boston, who voted yes on the proposition. I have spent decades caring for these patients, and we all wish we had fundamentally better options.
FDA initially granted atezolizumab, a PD-L1 immune checkpoint inhibitor, accelerated approval in 2019 in combination with nab-paclitaxel for patients with untreated metastatic or locally advanced unresectable TNBC whose tumors express PD-L1, based on findings from the IMpassion130 trial, which showed a significant