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On October 15, MSD announced that its anti-PD-1 therapy Keytruda has been approved by the FDA to expand new adaptations, single-drug treatments for adult patients with recurring or refractic classic Hodgkin's lymphoma (cHL).
press release, Keytruda is the first anti-PD-1 therapy approved for relapsed/refractic cHL adult patients who have received first-line therapy.
FDA also approved Keytruda for refractic cHL, or cHL children who relapse after treatment on the second and above.
Hodgkin's lymphoma is a tumor caused by lymphocytes, which are part of the immune system.
Hodgkin's lymphoma can occur almost anywhere in the body.
, there were about 80,000 new Cases of Hodgkin's Lymphoma in 2018, and more than 26,000 died as a result.
in developed countries, classic Hodgkin's lymphoma accounts for more than 90 percent of Hodgkin's lymphoma.
, a heavy-weight PD-1 inhibitor developed by Mercedon, activates T-cells and enhances their anti-cancer immune response by inhibiting the binding of PD-1 receptors expressed on the surface of T cells to their lids.
this approval is based on the results of phase 3 clinical trial KEYNOTE-204, in which Keytruda significantly reduced the patient's risk of disease progress or death by 35% compared to current standard therapies (HR=0.65, 95% CI, 0.48-0.88; p-lt;0.0027).
, the medium progression-free lifetime (PFS) was 13.2 months (95% CI, 10.9-19.4) for patients treated with Keytruda and 8.3 months (95% CI, 5.7-8.8) for patients treated with standard therapy.
Dr John Kuruvilla, a hematologist and associate professor of medicine at the Princess Margaret Cancer Centre at the University of Toronto, said: "The poor prognostication of cHL patients who do not have remission or recurrence after initial treatment reflects the unseatable need for improved therapies in this group.
approval, Keytruda has the potential to change current standards of care to help these patients achieve better outcomes.
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