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Roche Files PMA for Updated Cobas EGFR Test as CDx for AstraZeneca's AZD9291

NEW YORK (GenomeWeb) – Roche has submitted the Cobas EGFR Mutation Test v2 for premarket approval with the US Food and Drug Administration as a companion diagnostic to AstraZeneca's NSCLC drug AZD9291.

AZD9291 is a next-generation EGFR inhibitor for the two-thirds of NSCLC patients who relapse and develop resistance to older drugs, such as AstraZeneca's Iressa (gefitinib) and Genentech's Tarceva (erlotinib). The drug has breakthrough therapy designation, orphan drug and fast-track status from the FDA. At a medical meeting earlier this year, AstraZeneca reported that advanced NSCLC patients treated with AZD9291 had a median progression-free survival of 13.5 months with a 54 percent response rate that lasted more than a year for some.

Roche's Cobas EGFR Mutation Test v2 will be an updated version of its FDA-approved Cobas EGFR Test. According to the firm, the test will be able to identify a range of EGFR mutations that drive NSCLC, including the T790M resistance mutations. Last year, when Roche and AstraZeneca announced they would develop a CDx for AZD9291, the firms had highlighted that the test would be able to identify EGFR mutations in tumor tissue as well as plasma samples.

"AZD9291 was designed to inhibit both the activating sensitizing EGFR [mutations] and the resistance mutation, T790M," Antoine Yver, AstraZeneca's head of oncology, global medicines development, said in a statement. "The partnership with Roche on developing a companion diagnostics test for AZD9291 ensures that physicians will be able to identify the patients most likely to benefit from the treatment."

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