At the recommended Phase 3 dose of 200 mg vepdegestrant in combination with palbociclib, patients achieved a median progression-free survival of 13.9 months
Synthon will be responsible for obtaining US regulatory approval for Palbociclib Tablets
Palbociclib has a unique mechanism of action which helps in delaying disease progression when co-administered with hormonal therapies
IBRANCE is the first CDK4/6 inhibitor to show benefit in a large Phase 3 trial in first-line HR+, HER2+ metastatic breast cancer, in combination with anti-HER2 and endocrine therapy
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 setting
Shivalik Rasayan Limited have successfully submitted USMDF for API " Palbociclib " to USFDA
Dr. Reddy’s will manufacture the Active Pharmaceutical Ingredient and finished drug at its facilities approved by USFDA
The decision is based on the outcome of a prespecified interim analysis of the Phase 3 AMEERA-5 trial
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