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. Genentech Executive Levi Garraway, MD, PhD, called the approval "an important new first-line option for people living with HR+ breast cancer with a PIK3CA mutation" in a company press release.
FDA Approves New Drug Combination for ER+, HER2- Breast Cancer
The treatment combines a new drug, inavolisib, with two older breast cancer drugs, fulvestrant (Faslodex ®) and palbociclib (Ibrance ®) . Inavolisib, which targets PIK3CA mutations, appears to be a vital addition to making the triplet therapy more effective.
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.
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 Itovebi™ (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 Inavolisib in Locally Advanced, Metastatic Breast Cancer
Patients with endocrine-resistant, HER2-negative, locally advanced or metastatic breast cancer can use the treatment after recurrence or completing adjuvant endocrine 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 Genentech’s Itovebi, a Targeted Treatment for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation
FDA Approves Genentech’s Itovebi, a Targeted Treatment for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation
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,
Roche gets FDA approval for Itovebi combo therapy for breast cancer
Roche (RHHBY) has received FDA approval for its drug Itovebi in combination with two other drugs for the treatment of breast cancer with a PIK3CA mutation. Read more here.
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.
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