Roche's Tecentriq combo wins fast FDA review in race to catch rivals

[May 07, 2018] ZURICH (Reuters) - Roche's immunotherapy combination that includes Tecentriq, Avastin and chemotherapy will get an accelerated review by U.S. regulators for use as an initial treatment of a common form of lung cancer, the Swiss drugmaker said on Monday.

Roche expects a U.S. Food and Drug Administration decision by Sept. 5. It has already announced some results of clinical trials that showed the cocktail boosted survival benefit for patients with metastatic non-squamous non-small cell lung cancer (NSCLC) compared to older treatments.

Tecentriq is approved to treat NSCLC after other therapies fail, but Roche is pushing to deploy its medicine with other drugs as early as possible to catch up to better-established immunotherapies from Merck and Bristol-Myers Squibb.

Merck's Keytruda is approved for initial lung cancer treatment in some patients.

"We are working closely with the FDA to bring this treatment regimen to people with this type of lung cancer as soon as possible," said Sandra Horning, Roche's chief medical officer.

Tecentriq's status as a late-comer in immunotherapy compared to Keytruda and Bristol-Myers Squibb's Opdivo has contributed to sluggish sales.

In the first-quarter, Tecentriq revenue of 139 million Swiss francs ($138.9 million) lagged the 154 million poll estimate in a Reuters poll and was just above the 132 million of the fourth quarter, which analysts cited as a blemish on results.

Still, Roche points to numerous ongoing studies in lung and other cancers that include Tecentriq, contending it still had a shot at beating rivals to market in first-line treatment of small cell and first-line squamous cell lung cancer.

(Reporting by John Miller; Editing by Michael Shields)

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