Dabrafenib–trametinib approved for metastatic BRAF V600E-positive NSCLC
medwireNews: The US FDA has granted general approval for combined BRAF and MEK inhibitor therapy for patients with metastatic non-small-cell lung cancer (NSCLC) shown to have a BRAF V600E mutation.
Patients whose BRAF V600E mutation is confirmed by an FDA-approved test may be given dabrafenib 150 mg twice daily plus trametinib 2 mg once daily, following results from the Study BRF 113928 open-label trial.
Approval of the combination was announced alongside approval for the Oncomine DX Target Test (Thermo Fisher Scientific, USA), a next-generation sequencing test that can detect BRAF, ROS1, and EGFR aberrations from a single tissue sample from patients with NSCLC.
A second next-generation sequencing test has also received marketing approval, the Praxis Extended RAS Panel (Illumina Inc., USA) for patients with metastatic colorectal cancer. The test can detect 56 different KRAS and NRAS tumor mutations, the absence of which indicates patient suitability for treatment with the EGFR inhibitor panitumumab.
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