Genentech Says FDA Gives Accelerated Approval to Tecentriq Plus Chemotherapy

Date : 03/08/2019 @ 6:10PM
Source : Dow Jones News
Stock : Roche Holding (QX) (RHHBY)
Quote : 38.49  0.09 (0.23%) @ 9:36PM
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Genentech Says FDA Gives Accelerated Approval to Tecentriq Plus Chemotherapy

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   By Stephen Nakrosis 
 

Genentech on Friday said the U.S. Food and Drug Administration granted accelerated approval to Tecentriq plus chemotherapy for certain adult breast cancer patients.

The approval was based on data from the Phase III IMpassion130 study, which demonstrated that Tecentriq plus certain chemotherapy drugs significantly reduced the risk of the disease worsening or death, the company said. Safety appeared consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination, the company said.

Genentech said this Tecentriq combination is the first cancer immunotherapy regimen approved for breast cancer.

The FDA's Accelerated Approval Program can give faster approval of treatments for serious conditions where there is an unmet medical need.

Genentech is a member of the Roche Group.

 

Write to Stephen Nakrosis at stephen.nakrosis@wsj.com

 

(END) Dow Jones Newswires

March 08, 2019 12:55 ET (17:55 GMT)

Copyright (c) 2019 Dow Jones & Company, Inc.

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