FDA Approves EGFR Mutation Test for Lung Cancer Patients
The FDA has approved Roche's cobas EGFR Mutation Test, a companion diagnostic for Tarceva (erlotinib; Genentech). This test detects epidermal growth factor receptor (EGFR) gene mutations present in a percentage of non-small cell lung cancers (NSCLC). Accordingly, the FDA has approved Tarceva tablets for the first-line treatment of patients with metastatic NSCLC whose tumors have certain EGFR activating mutations as detected by an FDA-approved test.
The cobas EGFR Mutation Test is a real-time, polymerase chain reaction-based diagnostic test for the detection and identification of exon 19 deletion or exon 21 (L858R) substitution mutations in the EGFR gene in DNA derived from formalin-fixed, paraffin-embedded tumor (FFPET) tissue from NSCLC patients. Tarceva is an oral non-chemotherapy drug that inhibits EGFR, a protein involved in the growth and development of cancers.
The safety and efficacy of the cobas EGFR Mutation Test was demonstrated in clinical data that evaluated patients with specific EGFR mutations. In the study, treatment with Tarceva demonstrated that patients lived longer without their disease getting worse (median progression-free survival [PFS] 10.4 months vs. 5.2 months; HR=0.34; P<0.001 [95% CI 0.23–0.49]) compared to chemotherapy.
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