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 ...
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 ...
The Pharma Letter5d
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) ...
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 ...
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'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 ...
Medscape5d
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.
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 will cost $22,867 for a 28-day therapy cycle, a Genentech spokesperson said. In a late-stage clinical trial, Genentech said, the regimen with Itovebi, Pfizer's palbociclib, or Ibrance ...
Stockhouse6d
FDA Approves Genentech's Itovebi, a Targeted Treatment for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation
– Approval is based on Phase III INAVO120 results, showing the ItovebiTM (inavolisib)-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the ...