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Pivotal study demonstrated a clinically meaningful rate of tumor shrinkage (overall response rate) and duration of response in patients with previously-treated advanced cholangiocarcinoma (CCA) harboring
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Share this article Share this article 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 subs...
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 biomarke...
AZ' Tagrisso first to win MHRA approval under Project Orbis 7th May 2021 AstraZeneca's Tagrisso (osimertinib), a post-surgery treatment for lung cancer, is the first drug to receive approval from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Project Orbis. Project Orbis is a programme coordinated by the US Food and Drug Administration (FDA) with Canada, Australia, Switzerland, Singapore, Brazil and the UK as other participants, which offers a framework for concurrent submissions and collaboration reviews for promising cancer treatments. Tagrisso is licensed treatme...