FDA accepts application for license to supplement biologics for Mercay's heavy immunotherapy Keytruda
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Last Update: 2020-06-11
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Source: Internet
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Author: User
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recently, MSD announced thatFDA(receiving a supplementary biologic license application (sBLA) for its heavy immunotherapy Keytruda (pembrolizumab) for complementary treatment (adjuvant therapy) for patients with high-risk stage 3 melanoma who have undergone surgery to remove itkeytruda
Keytruda as a heavy immunotherapy, has demonstrated a wide range of therapeutic potential, as the main pushdrug(
) in MersadonIt selectively blocks PD-1 from binding to its ligands PD-L1 and PD-L2, allowing lymphatic T cells to identify and kill cancer cellsKeytruda has been approved for the treatment of a variety of cancers, such as melanoma, lung cancer, head and neck cancer, classic Hodgkin lymphoma, primary isolation of large B-cell lymphoma, urinary tract carpitoma, microsatellite instability (MSI-H) cancer, stomach cancer, etcOn June 12, the FDA approved Keytruda for advanced cervical cancer patients who develop edifying disease after chemotherapySeveraltrial(the effects of their single use or combination with other drugs are being assessed), with 10 clinical trials under way involving more than 4,500 patientsthis sBLA application is based on data from the key Phase 3 EORTC1325 / KEYNOTE-054 clinical trial dataThe results showed that Keytruda significantly longer relapsed survival (RFS) and reduced the risk of recurrence or death by 43% compared to placebo satouts in the overall study population (HR ?0.57 (98.4% CI, 0.43-0.74) ;p0.0001).
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