Mirati Therapeutics Inc. (MRTX) said that the U.S. Food and Drug Administration has granted accelerated approval for KRAZATI (adagrasib), a targeted treatment option for adult patients with KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer, as determined by an FDA-approved test, who have received at least one prior systemic therapy.
Continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial(s).
The company partnered with Agilent and QIAGEN to develop blood- and tissue-based companion diagnostics (CDx), respectively, for KRAZATI that are now available. With tissue and blood modalities for companion diagnostics, patients have more flexibility, and clinicians have greater options for biomarker testing.
MRTX closed Monday regular trading at $41.41 down $0.34 or 0.81%. But in the after-hours trade, the stock gained $3.38 or 8.16%.
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