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 ...

Roche Holding said the U.S. Food and Drug Administration granted priority review to the company's new drug application for inavolisib as a treatment for a type of advanced breast cancer.

Basel, 29 May 2024 - Roche (SIX ... or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment. The Priority Review is based on the ...

Roche said that the U.S. Food and Drug ... breast cancer treatment as a breakthrough therapy. A breakthrough therapy designation is given to accelerate the development and regulatory review ...

HER2-negative locally advanced or metastatic breast cancer that recurred (came back) on or within 12 months of postsurgical endocrine treatment. Roche, the manufacturer of inavolisib, announced the ...

Roche RHHBY obtained a Breakthrough Therapy Designation for its investigational oral therapy inavolisib for treating adult breast cancer patients in the United States. The FDA granted this ...

Analysts said the data suggest “a strong treatment effect.” Jazz has filed for FDA approval for the combination, which could ...

The designation is based on Phase III INAVO120 results, showing the inavolisib-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the ...