publication date: Jun. 30, 2016

Drugs and Targets FDA Approves EGFR Companion Diagnostic For Tarceva Therapy

 

FDA approved the cobas EGFR Mutation Test v2, a blood-based companion diagnostic for the cancer drug Tarceva (erlotinib). This is the first FDA-approved, blood-based genetic test that can detect epidermal growth factor receptor gene mutations in non-small cell lung cancer patients.

With the cobas test, the presence of specific NSCLC mutations [exon 19 deletion or exon 21 (L858R) substitution mutations] detected in patients’ blood samples aids in selecting those who may benefit from treatment with Tarceva. However, if such mutations are not detected in the blood, then a tumor biopsy should be performed to determine if the NSCLC mutations are present. Insofar as the test provides positive results, it may benefit patients who may be too ill or are otherwise unable to provide a tumor specimen for EGFR testing, according to FDA.

The test’s efficacy was determined by identifying EGFR mutation status in patients enrolled into a clinical trial whose tumor biopsies were previously confirmed positive for the EGFR exon 19 deletion or L858R mutations as determined by the cobas EGFR Mutation Test v1.

The FDA approved Tarceva in 2004 to treat patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen, and in 2013, the FDA approved it for the first-line treatment of … Continue reading CCL June 2016 – FDA Approves EGFR Companion Diagnostic For Tarceva Therapy

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