The Pharma Letter6d
FDA approves Genentech’s Itovebi for PIK3CA-mutated mBC
The Food and Drug Administration (FDA) approved Genentech's Itovebi (inavolisib), in combination with palbociclib (Ibrance) ...
Medscape6d
FDA Approves Inavolisib for HR+, HER2−, Advanced Breast Cancer With PIK3CA Mutation
The FDA also approved the FoundationOne Liquid CDx assay to identify patients who qualify for the newly approved treatment.
BioWorld5d
FDA gives early nod to Genentech’s first-line breast cancer drug
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 ...
FDA approves Genentech drug aimed at subset of breast cancer patients
The potential blockbuster drug was approved by the agency more than a month before its scheduled decision date. A potential ...
FDA Approves Genentech’s Itovebi, a Targeted Treatment for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug ...
Managed Healthcare Executive5d
FDA Approves Itovebi for Metastatic Breast Cancer
Itovebi is approved to treat patients with PIK3CA-mutated HR-positive, HER2 negative metastatic breast cancer in combination ...
healthandpharma3d
New First-Line Therapy: FDA Approves Itovebi for PIK3CA-Mutated Advanced Breast Cancer
The FDA has approved Genentech’s Itovebi™ (inavolisib) as a targeted therapy for adults with advanced hormone ...
Medpage Today on MSN7d
PI3K Inhibitor Wins FDA Approval for Advanced Breast Cancer
The FDA approved the PI3K-pathway inhibitor inavolisib (Itovebi) for use in combination with palbociclib (Ibrance) and ...
FDA Approves Genentech's Itovebi For Advanced Breast Cancer With PIK3CA Mutation
Genentech, a member of the Roche Group (RHHBY), said that the U.S. Food and Drug Administration approved Itovebi (inavolisib), in ...
Business Wire6d
FDA Approves Genentech’s Itovebi, a Targeted Treatment for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation
--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) approved Itovebiâ„¢ (inavolisib), in ...
The Business Journals7d
FDA approves Genentech drug aimed at subset of breast cancer patients
Itovebi — also known as inavolisib — is designed to be given ... chief medical officer for South San Francisco-based Genentech and Roche's head of global product development.