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Home » FDA gives early nod to Genentech’s first-line breast cancer drug
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FDA gives early nod to Genentech’s first-line breast cancer drug

Oct. 11, 2024
By Lee Landenberger
Genentech Inc. didn’t need to wait until Thanksgiving for the U.S. FDA to make up its mind. More than a month ahead of its PDUFA date, the agency approved the firm’s first-line breast cancer treatment, Itovebi (inavolisib), providing the oral therapy a place with other niched therapies from Astrazeneca plc and Novartis AG. Itovebi is to be combined with Pfizer Inc.’s palbociclib (Ibrance) and Faslodex (fulvestrant, Astrazeneca) for adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, HER2-negative, locally advanced or metastatic breast cancer.
BioWorld Regulatory Cancer Enzyme U.S. FDA

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