Astellas Submits Supplemental New Drug Application In Japan For PADCEV™ With KEYTRUDA® For First-Line Treatment Of Advanced Bladder Cancer
Portfolio Pulse from Benzinga Newsdesk
Astellas has submitted a supplemental new drug application in Japan for the combination of PADCEV™ (enfortumab vedotin) and KEYTRUDA® (pembrolizumab) as a first-line treatment for advanced bladder cancer. The pivotal trial showed that this combination significantly improved overall and progression-free survival compared to the current standard platinum-containing chemotherapy. If approved, it would be the first non-chemotherapy combination treatment for this condition in Japan.

January 31, 2024 | 6:34 am
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Astellas Pharma Inc. has submitted a supplemental new drug application in Japan for PADCEV with KEYTRUDA, potentially offering a new treatment option for advanced bladder cancer.
The submission of a new drug application in Japan for a combination treatment that could become the first non-chemotherapy option for advanced bladder cancer is likely to be viewed positively by investors. If approved, it could lead to increased revenue and market share for Astellas in the oncology sector.
CONFIDENCE 85
IMPORTANCE 80
RELEVANCE 90
POSITIVE IMPACT
Merck & Co., the maker of KEYTRUDA, could benefit from the supplemental new drug application submitted by Astellas in Japan as it is part of the combination treatment for advanced bladder cancer.
Merck & Co., as the manufacturer of KEYTRUDA, would potentially benefit from the expansion of its use in combination with PADCEV for treating advanced bladder cancer in Japan. Approval could lead to increased sales and an enhanced position in the oncology market.
CONFIDENCE 80
IMPORTANCE 60
RELEVANCE 70