Roche's Tecentriq wins U.S. approval for aggressive breast cancer

FILE PHOTO: The logo of Swiss drugmaker Roche is seen at its headquarters in Basel, Switzerland February 1, 2018. REUTERS/Arnd Wiegmann

ZURICH (Reuters) – Roche won U.S. approval on Friday of its immunotherapy Tecentriq to treat a significant slice of patients with aggressive triple-negative breast cancer, though the Swiss drugmaker still has work to do to prove its treatment’s merit.

The U.S. Food and Drug Administration (FDA) approved Tecentriq mixed with the chemotherapy Abraxane to treat inoperable, locally advanced or metastatic triple-negative breast cancer (TNBC) in people whose tumors express PD-L1, a protein that may help cancers avoid detection by the immune system.

Roughly 40 percent of the patients in Roche’s study had tumors with high PD-L1 levels.

The FDA’s approval was based on the drug cocktail’s record in studies that showed it delayed the progression of the disease. Roche, which is still awaiting overall survival data, said keeping the regulator’s blessing may depend on the results of further trials.

Roche’s Tecentriq has fallen behind immunotherapies Keytruda from Merck and Opdivo from Bristol-Myers Squibb in treatment areas such as lung cancer. It hopes beating the two rival therapies in indications like triple-negative breast cancer will help its medicine’s revenue accelerate.

“This Tecentriq combination is the first cancer immunotherapy regimen to be approved in breast cancer, representing a meaningful step forward in the understanding of this disease,” said Sandra Horning, Roche’s chief medical officer, in a statement.

Tecentriq’s 2018 sales were 772 million Swiss francs ($766 million), compared with $7.2 billion for Keytruda and $6.7 billion for Opdivo.

Reporting by John Miller; Editing by Mark Potter


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