Roche's Tecentriq cocktail hops into the FDA fast lane for another Merck showdown

tecentriq
Roche is now expecting word from the FDA on its Tecentriq-Avastin-chemo combo by early September. (Roche)

Roche’s Tecentriq-Avastin-chemo combo may have just scored quicker trip into the first-line lung cancer arena.

The company said Monday that the triplet won FDA priority review for previously untreated patients with advanced lung cancer, and that means it could go toe-to-toe with Merck & Co. by Sept. 5.

The regulatory boost follows data rolled out in late March, which showed the trio topped an Avastin-chemo combo at prolonging lung cancer patients’ lives. That survival benefit extended across various subgroups, too—including patients with tumors expressing varying levels of PD-L1, the biomarker Tecentriq is designed to target.

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If Roche can snag an FDA green light, it could mean new life for Avastin, an elder member of the Basel, Switzerland-based company’s cancer lineup. The agency has already approved Mvasi, a biosimilar version of the drug from Amgen and Allergan, in all of Avastin’s currently approved indications, including those in colorectal, lung, kidney and cervical cancers.

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The Roche regimen will have to go up against formidable competition from Merck, though. The drugmaker already has first-line approvals for solo immuno-oncology star Keytruda and a combo of Keytruda and chemo, and both treatment options have put up big efficacy numbers.

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Of course, until Roche puts out data on a Tecentriq-chemo pairing—sans Avastin—it’ll be an apples-to-oranges comparison with Merck’s chemo combo. Investors will be watching closely for those results, which are expected later this year.