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FDA Approves First Targeted Therapy for Subset of Non-Small Cell Lung Cancer

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SILVER SPRING, Md., May 21, 2021 /PRNewswire/ Today, the U.S. Food and Drug Administration approved Rybrevant (amivantamab-vmjw) as the first treatment for adult patients with non-small cell lung cancer whose tumors have specific types of genetic mutations: epidermal growth factor receptor (EGFR) exon 20 insertion mutations.
The FDA also approved the Guardant360 CDx (Guardant Health Inc.) as a companion diagnostic for Rybrevant today.
Advances in precision oncology continue to facilitate drug development, allowing diseases like lung cancer to be subset into biomarker-defined populations appropriate for targeted therapies, said Julia Beaver, M.D., chief of medical oncology in the FDA s Oncology Center of Excellence and acting deputy director of the Office of Oncologic Diseases in the FDA s Center for Drug Evaluation and Research. With today s approval, for the first time, patients with non-small cell lung cancer with EGFR ....

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FDA approves Rybrevant for treating subset of non-small cell lung cancer

FDA approves Rybrevant for treating subset of non-small cell lung cancer
Today, the U.S. Food and Drug Administration approved Rybrevant (amivantamab-vmjw) as the first treatment for adult patients with non-small cell lung cancer whose tumors have specific types of genetic mutations: epidermal growth factor receptor (EGFR) exon 20 insertion mutations.
The FDA also approved the Guardant360 CDx (Guardant Health Inc.) as a companion diagnostic for Rybrevant today.
Advances in precision oncology continue to facilitate drug development, allowing diseases like lung cancer to be subset into biomarker-defined populations appropriate for targeted therapies. With today s approval, for the first time, patients with non-small cell lung cancer with EGFR exon 20 insertion mutations will have a targeted treatment option. ....

United States , United Kingdom , Julia Beaver , Emily Henderson , Cdx Guardant Health Inc , Brazilian Health Regulatory Agency , Oncology Center , Drug Administration , Office Of Oncologic Diseases , American Cancer Society , Regulatory Agency , Guardant Health Inc , Medical Oncology , Oncologic Diseases , Drug Evaluation , American Cancer , Priority Review , Breakthrough Therapy , Janssen Pharmaceutical Companies , Project Orbis , ஒன்றுபட்டது மாநிலங்களில் , ஒன்றுபட்டது கிஂக்டம் , எமிலி ஹென்டர்சன் , புற்றுநோயியல் மையம் , அலுவலகம் ஆஃப் புற்றுநோயியல் நோய்கள் , அமெரிக்கன் புற்றுநோய் சமூகம் ,

FDA OKs First Targeted Therapy for Subset of Patients With NSCLC

FDA OKs First Targeted Therapy for Subset of Patients With NSCLC
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United States , Los Angeles , Karen Reckamp , Julia Beaver , Sinai Cancer Institute , Oncology Center , American Society Of Clinical Oncology , Drug Administration , Office Of Oncologic Diseases , Oncologic Diseases , Drug Evaluation , Cedars Sinai Cancer Institute , World Conference , Lung Cancer , American Society , Clinical Oncology , Annual Meeting , Project Orbis , ஒன்றுபட்டது மாநிலங்களில் , லாஸ் ஏஞ்சல்ஸ் , சினை புற்றுநோய் நிறுவனம் , புற்றுநோயியல் மையம் , அமெரிக்கன் சமூகம் ஆஃப் மருத்துவ புற்றுநோயியல் , அலுவலகம் ஆஃப் புற்றுநோயியல் நோய்கள் , புற்றுநோயியல் நோய்கள் , மருந்து மதிப்பீடு ,

FDA panel wrestles through multiday cancer drug meeting

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04/30/2021 12:00 PM EDT
With Sarah Owermohle, Alice Miranda Ollstein, Susannah Luthi, Rachel Roubein, Lauraine Genota, Emily Martin and Leah Nylen.
On Tap
Democrats hear a drug-pricing mandate from the president.
Regulators map out a path for eventually banning menthol cigarettes. ....

Bruxelles Capitale , United States , France General , White House , District Of Columbia , Astrazeneca Covid , Carolyn Maloney , David Lim , Carlo Martuscelli , Susannah Luthi , Joe Biden , Scott Kirby , Stephanie Beasley , Sarah Owermohle , Merck Keytruda , Mark Leahey , Leah Nylen , Biden Covid , Richard Pazdur , Marina Adami , Genetech Tecentriq , Janet Woodcock , Alice Miranda Ollstein , Mitch Zeller , Rachel Roubein , Emily Martin ,

FDA Panel Splits on Anti-PD-1 Monotherapy in HCC

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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 insig ....

North Carolina , United States , New Haven , Yale University , Pamela Kunz , Philip Hoffman , Richard Pazdur , Bristol Myers Squibb , Mark Lewis , Oncologic Drugs Advisory Committee , University Of Colorado , University Of Chicago , Yale University School Of Medicine , Office Of Oncologic Diseases , Yale University School , Intermountain Healthcare , Christopher Lieu , Such Luck , Anthony Sung , Duke Adult Blood , Marrow Transplant Clinic , Oncologic Diseases , Drug Evaluation , Managing Editor , Medpage Today , வடக்கு கரோலினா ,