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Page 4 - அலுவலகம் ஆஃப் புற்றுநோயியல் நோய்கள் News Today : Breaking News, Live Updates & Top Stories | Vimarsana

FDA Panel: Yank Keytruda Approval in Third-Line Gastric Cancer

email article 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.

FDA Watch: J&J Vaccinations Resume, Fake COVID-19 Therapies, Uterine Cancer Drug Fast-Tracked, Brie Cheese Recalls Over Salmonella Concern

Fact-Checked The FDA made several moves in April, from lifting the pause on the J&J vaccine to recalls on certain pills and vitamins. Bakhtiar Zein/iStock COVID-Related News The CDC and FDA have lifted the pause of the Johnson & Johnson vaccine following a complete review of rare blood clots. Following a thorough safety review including two meetings of the Centers for Disease Control and Prevention s (CDC) Advisory Committee on Immunization Practices the U.S. Food and Drug Administration (FDA) and the CDC issued a statement on April 23 saying that the recommended pause regarding the use of the Johnson & Johnson (Janssen) COVID-19 Vaccine in the United States should be lifted. Most States have resumed use of the vaccine.

FDA approves immunotherapy for treating patients with dMMR endometrial cancer

FDA approves immunotherapy for treating patients with dMMR endometrial cancer Today, the U.S. Food and Drug Administration granted accelerated approval to Jemperli (dostarlimab) for treating patients with recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing chemotherapy and whose cancers have a specific genetic feature known as dMMR (which contain abnormalities that affect the proper repair of DNA inside the cell), as determined by an FDA-approved test. Today s approval of Jemperli is evidence of the FDA s progress in applying precision medicine to expand treatment options for patients with cancer. This immunotherapy was specifically studied to target dMMR endometrial cancer and leverages scientific knowledge surrounding the mechanism of immunotherapy response in this unmet medical need population.

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