FDA approves Keytruda as adjuvant treatment for kidney cancer

fda approves keytruda as adjuvant treatment for kidney cancer

Sumary of FDA approves Keytruda as adjuvant treatment for kidney cancer:

  • The approval followed results of the pivotal Phase 3 KEYNOTE-564 trial study, in which Keytruda showed a significant reduction in the risk of disease recurrence or death by 32 percent compared to placebo.
  • (iStock) Dr. Toni K. Choueiri, primary investigator of the study and director of the Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, told Fox News that doctors have tried for decades to experiment with immunotherapy as a way to decrease recurrence in kidney cancer.
  • The phase 3 study involved multiple clinical sites, and was a randomized, double-blind placebo controlled trial that investigated the use of Keytruda as adjuvant therapy in 994 patients with intermediate-high or high risk of recurrence of RCC or M1 no evidence of disease (NED).
  • According to the recently published study in the New England Journal of Medicine, 496 patients were randomly assigned to receive pembrolizumab and 498 received a placebo.
  • The authors of the study found that pembrolizumab therapy was associated with significantly longer disease-free survival than placebo.
  • The study found at the 24-month follow-up, a 77.3 percent disease free survival in the KEYTRUDA group vs 68.1 percent in the placebo group.
  • BIDEN’S CLAIM THAT ‘DOGS MAY HELP CURE CANCER’ DRAWS TWITTER REACTIONSNick Pannone, a 62-year-old Cape Cod resident, participated in the KEYNOTE-564 clinical trial and told Fox news he was diagnosed with renal cell carcinoma three years ago and treated for prostate cancer six years ago.

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