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Mashup Score: 0
Mirati Therapeutics, Inc. ® (NASDAQ: MRTX), a commercial stage biotechnology company, today announced the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion on the Conditional Marketing Authorisation Application (MAA) for KRAZATI ® ( adagrasib ) for treatment of patients with KRAS G12C -mutated advanced non-small cell lung cancer (NSCLC). Mirati disagrees with the opinion and intends to request a formal re-examination. CHMP states that KRAZATI has a positive risk-benefit profile, however, does not fulfill certain requirements for a Conditional Marketing Authorisation. Mirati believes KRAZATI addresses the Conditional Marketing Authorisation requirements despite there being a currently conditionally approved KRAS G12C inhibitor and that KRAZATI possesses a differentiated clinical profile. Key differentiators include KRAZATI’s efficacy profile, potential central nervous system activity and combinability with other agents,
Source: ir.mirati.comCategories: Hem/Oncs, Latest HeadlinesTweet
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Mashup Score: 32
Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to adagrasib for the potential treatment of patients with non-small cell lung cancer (NSCLC) who harbor the KRAS G12C mutation following prior systemic therapy. Breakthrough Therapy Designation is an FDA…
Source: ir.mirati.comCategories: Hem/Oncs, Latest HeadlinesTweet-
RT @DrMarkAwad: Adagrasib now has FDA breakthrough designation for KRAS G12C mutant NSCLC! @kRasKickers https://t.co/n8kZR8FbBG
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Mashup Score: 7
Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to adagrasib for the potential treatment of patients with non-small cell lung cancer (NSCLC) who harbor the KRAS G12C mutation following prior systemic therapy. Breakthrough Therapy Designation is an FDA…
Source: ir.mirati.comCategories: Hem/Oncs, Latest HeadlinesTweet-
⭐️Adagrasib Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration for Patients with Advanced Non-Small Cell Lung Cancer Harboring the KRAS G12C Mutation https://t.co/bQoX5fLI5z
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PressRelease🚨 @EMA_News issued a negative opinion on the Marketing Authorization Application (MAA) for adagrasib @Mirati for treatment of patients with KRASG12C-mutated advanced NSCLC 🔨 @KRASKickers https://t.co/K3bi11rGcZ