Roche's Genentech Granted Priority Review By FDA For Inavolisib, An Investigational Oral Therapy, In Combination With Palbociclib (Ibrance) And Fulvestrant
Portfolio Pulse from Benzinga Newsdesk
Roche's Genentech has been granted Priority Review by the FDA for Inavolisib, an investigational oral therapy, in combination with Palbociclib (Ibrance) and Fulvestrant. The FDA decision is expected by November 27, 2024. This regimen targets PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer.
May 29, 2024 | 5:08 am
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POSITIVE IMPACT
Pfizer's Palbociclib (Ibrance) is part of the combination therapy with Inavolisib that has received FDA Priority Review. This could enhance the drug's market presence and sales if approved.
As part of the combination therapy, Pfizer's Ibrance could see increased usage and sales if the FDA approves the regimen, positively impacting Pfizer's revenue from this drug.
CONFIDENCE 80
IMPORTANCE 70
RELEVANCE 50
POSITIVE IMPACT
Roche's Genentech has received FDA Priority Review for Inavolisib in combination with Ibrance and Fulvestrant, indicating strong potential for a new cancer treatment. The FDA decision is expected by November 27, 2024.
The FDA Priority Review status suggests a high likelihood of approval, which could significantly boost Roche's market position in cancer treatments. The decision date provides a clear timeline for investors.
CONFIDENCE 90
IMPORTANCE 90
RELEVANCE 100