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29 May 2026, 10:45 UTC · 8h ago

FDA Grants Breakthrough Therapy Designation for Calderasib (MK-1084), an Investigational KRAS G12C Inhibitor, for Certain Patients with Newly Diagnosed Metastatic KRAS G12C-Mutant Non-Small Cell Lung Cancer (NSCLC)

Source · https://www.businesswire.com/news/home/20260529095946/en/FDA-Grants-Breakthrough-Therapy-Designation-for-Calderasib-MK-1084-an-Investigational-KRAS-G12C-Inhibitor-for-Certain-Patients-with-Newly-Diagnosed-Metastatic-KRAS-G12C-Mutant-Non-Small-Cell-Lung-Cancer-NSCLC/

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FDA Grants Breakthrough Therapy Designation for Calderasib (MK-1084), an Investigational KRAS G12C Inhibitor, for Certain Patients with Newly Diagnosed Metastatic KRAS G12C-Mutant Non-Small Cell Lung Cancer (NSCLC)

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The FDA granted Breakthrough Therapy designation to the combination of calderasib and Keytruda for first-line treatment of advanced or metastatic NSCLC with KRAS G12C-mutation. — Breakthrough designation accelerates the regulatory path for a potentially high-revenue treatment in a major cancer indication.
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The FDA granted Breakthrough Therapy designation to a combination of the company's investigational drug and KEYTRUDA.

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FDA Grants Breakthrough Therapy Designation for Calderasib (MK-1084), an Investigational KRAS G12C Inhibitor, for Certain Patients with Newly Diagnosed Metastatic KRAS G12C-Mutant Non-Small Cell Lung Cancer (NSCLC)

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FDA Grants Breakthrough Therapy Designation for Calderasib (MK-1084), an Investigational KRAS G12C Inhibitor, for Certain Patients with Newly Diagnosed Metastatic KRAS G12C-Mutant Non-Small Cell Lung Cancer (NSCLC)

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Menarini Group presenta nuevos datos del estudio ELEVATE de elacestrant en combinación con capivasertib

FDA Grants Breakthrough Therapy Designation for Calderasib (MK-1084), an Investigational KRAS G12C Inhibitor, for Certain Patients with Newly Diagnosed Metastatic KRAS G12C-Mutant Non-Small Cell Lung Cancer (NSCLC)

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Sentiment in this article

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