CHMP positive for Krazati (adagrasib)to treat KRASG12C -mutated advanced non-small cell lung cancer .- Mirati Therapeutics
Mirati Therapeutics, Inc. announced that following a re-examination procedure, the Company has received a positive opinion from the European Medicine Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) on Krazati (adagrasib) as a targeted treatment option for adult patients with KRASG12C -mutated advanced non-small cell lung cancer (NSCLC) and disease progression after at least one prior systemic therapy.
"This positive opinion from the CHMP for Krazati marks an important step on the path to providing access to a potentially best-in-class therapeutic option to patients living with this difficult-to-treat disease," Alan Sandler, M.D., chief medical officer, Mirati Therapeutics, Inc. "We look forward to approval from the European Commission and the opportunity to positively impact the lives of eligible patients living in the European Union."
"This is an important day for the oncology community as we step closer to a new therapeutic option being available to patients living with KRASG12C mutated NSCLC in the European Union," said Martin Reck, MD, PhD, Lung Clinic Grosshansdorf, Germany. "Every patient has a slightly different case so as more options become available physicians will better be able to tailor their treatment for each patient."
The benefits of Krazati are its objective response rate and response duration in patients with KRAS G12C-mutated NSCLC who had disease progression after receiving prior therapy. The most common side effects are diarrhoea, nausea, vomiting, fatigue, hepatotoxicity and anaemia.
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