Roche Holding (QX) (USOTC:RHHBY)
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1 Year : From Dec 2018 to Dec 2019
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 firstname.lastname@example.org
(END) Dow Jones Newswires
March 08, 2019 12:55 ET (17:55 GMT)
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