QGEN - Qiagen's test gets FDA nod for companion diagnostic to Mirati's cancer drug Krazati
- The U.S. Food and Drug Administration (FDA) approved Qiagen's ( NYSE: QGEN ) therascreen KRAS RGQ PCR kit as a companion diagnostic test to Mirati Therapeutics ( NASDAQ: MRTX ) Krazati which was approved yesterday to treat non-small cell lung cancer (NSCLC).
- Qiagen said the tissue based KRAS test identifies patients with NSCLC that have a KRAS G12C mutation, who may benefit from treatment with Krazati (adagrasib).
- Yesterday, the FDA granted accelerated approval to Krazati to treat adult patients with with KRASG12C-mutated locally advanced or metastatic NSCLC, who have received at least one prior systemic therapy.
- The companies had announced their cooperation in May 2021.
- Qiagen noted that it was the fourth approval of its therascreen KRAS RGQ PCR kit, adding to the existing 3 therapies already indicated in the label for use in NSCLC and colorectal cancer
- MRTX +15.79% to $47.95 premarket Dec. 13
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Qiagen's test gets FDA nod for companion diagnostic to Mirati's cancer drug Krazati