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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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An advisory committee recommended that the FDA revoke the accelerated approval for pembrolizumab (Keytruda) as a third-line option in gastric or gastroesophageal junction (GEJ) cancer.
With a vote of 6-2, the Oncologic Drugs Advisory Committee (ODAC) on Thursday recommended against maintaining the PD-1 immune checkpoint inhibitor s indication for patients with metastatic or recurrent locally advanced gastric or GEJ cancers with tumors expressing PD-L1.
Committee members overwhelmingly cited the new availability of a PD-1 inhibitor, in combination with chemotherapy, in the upfront setting, as well as the fact that patients who have already received chemotherapy alone as their initial therapy could still access pembrolizumab through expanded use programs.
Sara Schottenstein Foundation Announces Launch; Dedicated To Ending Gastric Cancer
Foundation honors wife, mother and attorney Sara Schottenstein
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TIBURON, Calif., Jan. 21, 2021 /PRNewswire/ The Sara Schottenstein Foundation, a science-focused organization dedicated to ending gastric cancer, today announced its launch and new website, http://www.saraschottensteinfoundation.org/. Founded by Jeff Schottenstein, a wealth management professional in San Francisco, the Sara Schottenstein Foundation supports innovative gastric cancer research, raises awareness, and champions patients and their caregivers. It also honors Sara Schottenstein (1967-2016), Jeff s late wife, and her inspirational life and efforts to overcome gastric cancer.