healthday1d
FDA Approves Itovebi for Locally Advanced, Metastatic Breast Cancer
WEDNESDAY, Oct. 16, 2024 (HealthDay News) -- The U.S. Food and Drug Administration approved Itovebi (inavolisib), in ...
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 ...
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 ...
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 ...
The American Journal of Managed Care5d
FDA Approves Inavolisib in Locally Advanced, Metastatic Breast Cancer
Patients with endocrine-resistant, HER2-negative, locally advanced or metastatic breast cancer can use the treatment after ...
precisionmedicineonline5d
FDA Approves Genentech's Itovebi Combo for PIK3CA-Mutated Advanced Breast Cancer Patients
In the INAVO120 trial, Itovebi added to Pfizer's Ibrance and fulvestrant doubled progression-free survival versus Ibrance and fulvestrant alone.
Cancer Therapy Advisor6d
Itovebi Approved for Advanced Breast Cancer With PIK3CA Mutations
The FDA has approved Itovebi in combination with palbociclib and fulvestrant to treat certain patients with PIK3CA-mutant breast cancer.
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.
FDA Approves Roche’S Itovebi, A Targeted Treatment For Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With A PIK3CA Mutation
Itovebi is Roche's first targeted therapy approved for people with HR-positive disease, the most prevalent breast cancer subtype, marking an important step in our ambition to continue bringing ...
BioWorld6d
FDA gives early approval to Genentech’s first-line breast cancer treatment
PDUFA date, the U.S. FDA has approved Genentech Inc.’s first-line breast cancer treatment Itovebi (inavolisib). Itovebi is to be combined with Pfizer Inc.’s palbociclib (Ibrance) and fulvestrant for ...
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 ...