Accelerated Approvals Withdrawn for Ibrutinib in Mantle Cell Lymphoma, Marginal Zone Lymphoma
April 7th 2023Accelerated approvals for ibrutinib (Imbruvica) for patients with mantle cell lymphoma and with marginal zone lymphoma voluntarily withdrawn based on data that were insufficient to support conversion to full approval.
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FDA Accepts Supplemental New Drug Application for Encorafenib, Binimetinib Combination in NSCLC
April 6th 2023The application is based on the PHAROS trial, which met its primary endpoint of objective response rate in patients with metastatic non–small cell lung cancer with a BRAF V600E mutation.
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