CHMPrefuses recommendation for Krazati as a treatment of advanced non-small cell lung cancer with a KRAS G12C mutation
Mirati Therapeutics, Inc. a commercial stage biotechnology company, 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 KRASG12C -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 KRASG12C 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, including concurrent with or following treatment with an immune checkpoint inhibitor.
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