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

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.

Free Daily Newsletter

Like this story? Subscribe to FiercePharma!

Biopharma is a fast-growing world where big ideas come along daily. Our subscribers rely on FiercePharma as their must-read source for the latest news, analysis and data on drugs and the companies that make them. Sign up today to get pharma news and updates delivered to your inbox and read on the go.

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.

RELATED: Roche's latest Tecentriq results shed little light on the lung cancer market race: analyst

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.

RELATED: 2018 is here. Now get ready for ‘market-defining’ I-O readouts

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.

Suggested Articles

The FDA has handed down its decision against Sanofi and Lexicon's Zynquista.

Analysts with Cortellis expect seven blockbuster drug launches in markets across the world this year. AbbVie's upadacitinib leads the pack.

The new Alcon shares will be listed on the Swiss Exchange and the New York Stock Exchange on April 9 under the ticker “ALC.”