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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 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,
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.
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 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,
FDA approves Genentech drug aimed at subset of breast cancer patients
A potential blockbuster cancer drug developed by Genentech Inc. and parent company Roche won regulatory approval Thursday to treat a subset of breast cancer patients, more than a month ahead of its scheduled decision date.
Genentech Itovebi Gets FDA Approval for Treating Breast Cancer
Roche Group unit Genentech said that the Food and Drug Administration approved Itovebi for treating certain breast cancer. The approval is for Itovebi in combination with palbociclib and fulvestrant and for treating adults a certain locally advanced or metastatic breast cancer,
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 Administration (FDA) approved Itovebiâ„¢ (inavolisib), in combination with palbociclib (Ibrance®) and fulvestrant,
GlobalData on MSN
3d
Roche wins first-line approval for PI3K inhibitor combo in breast cancer
The US FDA approved Itovebi in combination with Pfizer’s Ibrance and AstraZeneca’s Faslodex as the first-line treatment for ...
BioSpace
4d
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 ...
The Pharma Letter
1d
The week in pharma: action, reaction and insight – week to October 11
Significant research news last week saw US biotech Scholar Rock release positive new data for its spinal atrophy (SMA) ...
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