FDA Grants Full Approval For Blincyto To Treat Minimal Residual Disease-Positive B-Cell Precursor Acute Lymphoblastic Leukemia
Portfolio Pulse from Happy Mohamed
The FDA has granted full approval for Amgen's BLINCYTO to treat minimal residual disease-positive B-cell precursor acute lymphoblastic leukemia. The approval is based on additional data from two Phase 3 studies and converts BLINCYTO's accelerated approval to a full approval.
June 21, 2023 | 1:01 pm
News sentiment analysis
Sort by:
Ascending
POSITIVE IMPACT
Amgen's BLINCYTO receives full FDA approval for treating minimal residual disease-positive B-cell precursor acute lymphoblastic leukemia, potentially boosting the company's market position.
The FDA's full approval of BLINCYTO is a significant milestone for Amgen, as it reinforces the drug's position as a standard of care for patients with minimal residual disease at baseline after remission. This approval is based on additional data from two Phase 3 studies, which further validates the drug's efficacy and safety. The full approval is likely to have a positive impact on Amgen's stock price in the short term, as it strengthens the company's market position and potentially expands the drug's market reach.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100