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Roche Wins FDA Nod for Breast Cancer Drug in First-Line Setting
Roche RHHBY announced that the FDA has approved pipeline candidate, inavolisib, for the treatment of breast cancer, under the brand name Itovebi. The drug is approved in combination with Pfizer’s Ibrance (palbociclib) and fulvestrant for the treatment of adults with endocrine-resistant,
New Drug Approved for Common Type of Breast Cancer Recurrence
A new breast cancer drug has received quick federal approval after a clinical trial showed it could more than double the time before a common type of breast cancer recurrence worsens.
Roche gets FDA green light for breast cancer drug Itovebi
Novartis' Piqray/Vijoice (alpelisib) is the only PIK3CA inhibitor to have reached the market for breast cancer, having been cleared in 2019 as a second-line therapy alongside fulvestrant for this group of patients whose cancer has progressed on or after endocrine-based therapy.
Roche gets FDA approval for Itovebi combo therapy for breast cancer
Roche (OTCQX:RHHBY) has received FDA approval for its drug Itovebi in combination with two other drugs for the treatment of a certain type of breast cancer with a PIK3CA mutation. The agency approved Itovebi in combination with Pfizer’s (PFE) Ibrance and fulvestrant for the treatment of endocrine-resistant,
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 with Ibrance and fulvestrant.
Roche burnishes breast cancer portfolio with FDA approval for Itovebi, a threat to Novartis and AZ
As Roche comes under competitive pressure on its breast cancer business, the Swiss company hopes a new drug will add a 2-billion-Swiss-francs luster to the once high-flying portfolio. | As Roche comes under competitive pressure on its breast cancer business,
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.
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) and fulvestrant, for the treatment of adults with endocrine-resistant, PIK3CA-mutated,
FDA Approves Itovebi Combo for Some With Advanced Breast Cancer
The Food and Drug Administration (FDA) has approved Itovebi (inavolisib) with Ibrance (palbociclib) and Faslodex (fulvestrant) for certain patients with advanced or metastatic breast cancer.
FDA approves Roche’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 Itovebiâ„¢ (inavolisib)-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting1This approval helps address an urgent unmet need in breast cancer for people with a PIK3CA mutation,
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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 ...
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Roche Wins First-Line Breast Cancer Nod for Oral PI3K Blocker, Projects $2.3B in Peak Sales
With the regulatory approval for advanced breast cancer, Roche’s inavolisib is a potential challenger to Novartis’ PI3K ...
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