FDA approves Merck and Astellas-Seagen's combination treatment for bladder cancer
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- The U.S. Food and Drug Administration (FDA) on Monday approved a combination treatment of Merck's (NYSE:MRK) Keytruda with Astellas Pharma (OTCPK:ALPMF) (OTCPK:ALPMY) and Seagen's (SGEN) Padcev for the treatment of certain patients with bladder cancer.
- The exact indication for the combination was for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (la/mUC) who are not eligible for cisplatin-containing chemotherapy.
- "This marks the first time an anti-PD-1 therapy has been approved in combination with an antibody-drug conjugate in the U.S. in these patients," MRK said in a statement.
- The FDA's approval was based on data from a dose escalation trial conducted in collaboration with Astellas (OTCPK:ALPMF) (OTCPK:ALPMY) and Seagen (SGEN).
- The indication was approved under the FDA's accelerated approval process, based on tumor response rate and durability of response, MRK said.