Seagen Says FDA Grants Priority Review For Supplemental Biologics License Application (sBLA) Of PADCEV (enfortumab vedotin-ejfv) With KEYTRUDA (pembrolizumab) For First-Line Treatment Of Advanced Bladder Cancer
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Seagen announced that the FDA has granted priority review for the sBLA of PADCEV in combination with KEYTRUDA for the first-line treatment of advanced bladder cancer. This could expedite the approval process, potentially benefiting patients with advanced bladder cancer.
November 30, 2023 | 10:03 pm
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POSITIVE IMPACT
Merck's KEYTRUDA, used in combination with Seagen's PADCEV, has received priority review from the FDA for the treatment of advanced bladder cancer, which may enhance the drug's market presence.
Merck's KEYTRUDA is already a well-established cancer therapy, and the priority review for its combination with PADCEV could lead to expanded indications and increased usage. This development is likely to be seen as positive by investors, potentially leading to a short-term positive impact on Merck's stock price.
CONFIDENCE 75
IMPORTANCE 75
RELEVANCE 70
POSITIVE IMPACT
Seagen's PADCEV, in combination with KEYTRUDA, has been granted priority review by the FDA for advanced bladder cancer, which could lead to faster approval and increased sales.
The priority review status by the FDA is a positive development for Seagen, indicating a significant regulatory milestone that could lead to increased revenue from PADCEV if approved. This news is likely to be viewed positively by investors, potentially leading to a short-term uptick in Seagen's stock price.
CONFIDENCE 80
IMPORTANCE 85
RELEVANCE 90