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Merck announced that the U.S. Food and Drug Administration (FDA) has approved the expansion of Merck's anti-PD-1 single-anti-KEYTRUDA for adult patients with relapsed or refractic classic Hodgkin's lymphoma (cHL) progressing after first-line treatment.
this approval is based on the results of the KEYNOTE-204 Phase 3 clinical trial, which significantly reduced the risk of disease progress or death by 35% compared to Brentuximab vedotin.
, the medium progression-free lifetime (PFS) was 13.2 months for patients treated with KEYTRUDA and 8.3 months for patients treated with BV.
KEYTRUDA may have severe or fatal immuno-mediated adverse reactions, including pneumonia, colitis, hepatitis, endocrine lesions, nephritis, severe skin reactions, rejection of solid organ transplantation, and complications of isotopic stem cell transplantation (HSCT).
depending on the severity of the adverse reaction, keyTRUDA should be deactivation and corticosteroids should be taken where appropriate.
keyTRUDA may also cause serious or life-threatening infusion-related reactions.
according to its action, pregnant women taking KEYTRUDA can cause fetal injury. Dr John Kuruvilla, associate professor of hematology and medicine at
, said: "The poor prognosis of cHL patients who have not been alleviated after initial treatment or who have relapsed after transplantation reflects the unsecured need for improved therapy in patients with recurrence/refractability.
the approval of KEYTRUDA may help these patients achieve better results.
"