Biotechnology company Seagen Inc. (SGEN) and Tokyo-based Astellas Pharma Inc. on Friday reported positive results from a Phase 3 trial of their experimental bladder cancer medicine, Padcev, in combination with Merck’s (MRK) Keytruda.
Key Takeaways
- Biotech company Seagen and Japanese partner Astellas Pharma reported positive results from a late-stage trial of their experimental bladder cancer drug combined with Merck's Keytruda.
- The drug, Padcev, and Keytruda met key endpoints in patients with metastatic urothelial cancer.
- After the news was reported Friday, shares of Seagen rose to an all-time high.
- Seagen and Astellas said the study was intended to help seek accelerated approval of the drug combination from the U.S. Food and Drug Administration (FDA).
The Padcev-Keytruda treatment was given to those who had previously untreated locally advanced or metastatic urothelial cancer (la/mUC), a form of bladder cancer that has spread to surrounding muscles, organs or other parts of the body.
The companies said that the study met key endpoints for patients who received the drug combination versus those who took a placebo.
They noted that this study was intended to serve as a basis for global submissions and as a confirmatory trial for accelerated approval from the U.S. 澳洲幸运5官方开奖结果体彩网:Food and Drug Administration (FDA). In April, the FDA gave accelerated approval of the Padcev-Keytruda treatment in certain adults with la/mUC.
Dr. Ahsan Arozullah, senior vice president and head of oncology development at Astellas, said patients with metastatic urothelial cancer “are in dire need of additional treatment options and this combination has the potential to advance the standard of care.”
After the news was reported, shares of Seagen rose to an all-time high. Merck ⛦shares were little changed at midday Friday.
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