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默克公司Keytruda标签在美国扩大,用于间皮瘤

2024-09-18 19:08

  • Merck (NYSE:MRK) announced Wednesday that the U.S. Food and Drug Administration (FDA) approved a label expansion for its blockbuster therapy Keytruda to allow its use as a first-line combination therapy for mesothelioma, a cancer in the linings of internal organs.
  • Accordingly, Keytruda will be available in the U.S. for use with pemetrexed and platinum chemotherapy as a first-line option for adults with unresectable advanced or metastatic malignant pleural mesothelioma.
  • The decision was based on data from Merck's (MRK) Phase 2/3 KEYNOTE-483 trial, which demonstrated that Keytruda plus chemotherapy improved key cancer therapy metrics such as overall survival compared to chemotherapy alone with a statistically significant effect.
  • The anti-PD1 therapy is approved for more than 41 indications in the U.S., and the latest approval marks its first indication in malignant pleural mesothelioma.

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