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


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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. ....

United States , New York , Memorial Sloan Kettering Cancer Center , New Haven , Yale University , Pamela Kunz , Richard Pazdur , Colin Weekes , Diane Reidy Lagunes , Oncologic Drugs Advisory Committee , University Of Colorado , Yale University School Of Medicine , Office Of Oncologic Diseases , Massachusetts General Hospital , Christopher Lieu , New York City , Yale University School , Oncologic Diseases , Drug Evaluation , Managing Editor , Medpage Today , ஒன்றுபட்டது மாநிலங்களில் , புதியது யார்க் , நினைவகம் ஸ்லோன் கெட்டரிங் புற்றுநோய் மையம் , புதியது புகலிடம் , யேல் பல்கலைக்கழகம் ,

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


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The FDA made several moves in April, from lifting the pause on the J&J vaccine to recalls on certain pills and vitamins.
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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. ....

Richard Pazdur , Carefusion Alaris , Christopherm Loftus , Dostarlimab Jemperli , Oncology Center , Radiological Health , Office Of Neurological , Office Of Oncologic Diseases , Oncologic Diseases , Drug Evaluation , Ipsihand System , Physical Medicine Devices , புற்றுநோயியல் மையம் , கதிரியக்கவியல் ஆரோக்கியம் , அலுவலகம் ஆஃப் நரம்பியல் , அலுவலகம் ஆஃப் புற்றுநோயியல் நோய்கள் , புற்றுநோயியல் நோய்கள் , மருந்து மதிப்பீடு , உடல் மருந்து சாதனங்கள் ,

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. ....

United States , Richard Pazdur , Emily Henderson , Oncology Center , Drug Administration , Office Of Oncologic Diseases , Acting Director , Oncologic Diseases , Drug Evaluation , Priority Review , Breakthrough Therapy , Accelerated Approval , ஒன்றுபட்டது மாநிலங்களில் , எமிலி ஹென்டர்சன் , புற்றுநோயியல் மையம் , அலுவலகம் ஆஃப் புற்றுநோயியல் நோய்கள் , நடிப்பு இயக்குனர் , புற்றுநோயியல் நோய்கள் , மருந்து மதிப்பீடு , ப்ரையாரிடீ விமர்சனம் , திருப்புமுனை சிகிச்சை , முடுக்கப்பட்ட ஒப்புதல் ,