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FDA grants Breakthrough Therapy Designation to Roche's inavolisib for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation

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. ....

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F. Hoffmann-La Roche Ltd: FDA grants Breakthrough Therapy Designation to Roche's inavolisib for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation

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 first-line ....

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Roche, Genentech: Inavolisib Gets FDA Breakthrough Status To Treat Breast Cancer With Mutation

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. ....

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F. Hoffmann-La Roche Ltd: Roche reports positive Phase I results for its dual GLP-1/GIP receptor agonist CT-388 in people with obesity

F. Hoffmann-La Roche Ltd: Roche reports positive Phase I results for its dual GLP-1/GIP receptor agonist CT-388 in people with obesity
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[Ad hoc announcement pursuant to Art. 53 LR] Roche reports positive Phase I results for its dual GLP-1/GIP receptor agonist CT-388 in people with obesity

Over 24 weeks, a once-weekly subcutaneous injection of CT-388 achieved a clinically meaningful and statistically significant mean placebo-adjusted weight loss of 18.8% At week 24, 100% of CT-388. ....

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