Roche, inavolisib
Roche Breast Cancer Medicine to Get Expedited FDA Review
Roche Holding AG said an experimental breast-cancer treatment will get an expedited review from US regulators after showing it helped patients live longer without the disease progressing.The decision is based on research showing the medicine,
Roche’s PI3K inhibitor wins FDA priority review for breast cancer
The US FDA has set an action date of 27 November for the combination therapy of Roche’s inavolisib, Pfizer’s Ibrance, and fulvestrant.
Roche Breast-Cancer Drug Gets Priority Review in the U.S.
By Adria Calatayud Roche Holding said the U.S. Food and Drug Administration granted priority review to the company's new drug application for inavolisib as
Roche’s PI3K inhibitor secures breakthrough status in breast cancer
The US Food and Drug Administration (FDA) has granted Roche a breakthrough therapy designation for its breast cancer therapy inavolisib, based on positive results from its recent Phase III trial.
Inavolisib Combo Gets FDA Priority Review in HR-Positive, HER2-Negative Breast Cancer
The priority review is based on findings from a study that found that inavolisib reduced the risk for disease progression or death by 57%.
Roche's Inavolisib Breast Cancer Treatment Gets FDA Breakthrough Therapy Designation
By Pierre Bertrand Roche said that the U.S. Food and Drug Administration has designated its Inavolisib breast cancer treatment as a breakthrough therapy.
Roche Cancer Drug Gets Breakthrough Therapy Designation
Roche (OTC: RHHBY) obtained a Breakthrough Therapy Designation for its investigational oral therapy inavolisib for treating adult breast cancer patients in the United States.
Inavolisib Regimen Wins FDA Priority Review for PIK3CA Breast Cancer
Data from the phase 3 INAVO120 trial support the priority review granted by the FDA to inavolisib, palbociclib, and fulvestrant for the treatment of PIK3CA-mutated breast cancer.
Roche, Genentech: Inavolisib Gets FDA Breakthrough Status To Treat Breast Cancer With Mutation
(RTTNews) - Swiss drug major Roche Holding AG (RHHBY) and its U.S. Unit Genentech announced Tuesday that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation for inavolisib to treat advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation.
FDA Grants Priority Review to Genentech's Inavolisib NDA in Breast Cancer
The agency is slated to decide in November whether to approve the PI3Kα inhibitor as a first-line option for PIK3CA-mutated advanced breast cancer.
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FDA Grants Priority Review To Genentech's Inavolisib For Advanced HR+, HER2- Breast Cancer Mutation
(RTTNews) - Genentech, a member of the Roche Group (RHHBY), said that the U.S. Food and Drug Administration has accepted the company's New Drug Application and granted Priority Review to ...
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FDA to Review Inavolisib Combo for HR-Positive, HER2-Negative Breast Cancer
The Food and Drug Administration granted a breakthrough therapy designation to inavolisib plus Ibrance and fulvestrant for HR ...