Merck gets USFDA approval for adjuvant Keytruda for pediatric, adult Melanoma
Kenilworth: Merck, known as MSD outside the United States and Canada, has announced that the U.S. Food and Drug Administration (USFDA) has approved KEYTRUDA, Merck's anti-PD-1 therapy, for the adjuvant treatment of adult and pediatric (12 years and older) patients with stage IIB or IIC melanoma following complete resection.
Additionally, the FDA expanded the indication for KEYTRUDA as adjuvant treatment for stage III melanoma following complete resection to include pediatric patients (12 years and older).
The approval in stage IIB and IIC melanoma is based on data from the first interim analysis of the Phase 3 KEYNOTE-716 trial, in which KEYTRUDA showed a statistically significant improvement in recurrence-free survival (RFS), reducing the risk of disease recurrence or death by 35% (HR=0.65 [95% CI, 0.46-0.92]; p=0.0132) compared to placebo. Median RFS was not reached for either group. After a median follow-up of 14.4 months, 11% (n=54/487) of patients who received KEYTRUDA had recurrence or died compared to 17% (n=82/489) of patients who received placebo. Efficacy in pediatric patients (12 years and older) with stage IIB, IIC and III melanoma is supported by extrapolation of efficacy data from adults, given similar biology, pharmacology of drug effect, as well as similar exposure-response for efficacy and safety.
"The standard of care for patients with resected stage IIB and IIC melanoma has been observation, despite the fact that for these patients, the risk of recurrence is nearly the same as for patients with later-stage disease for whom treatment is recommended," said Dr. Jason Luke, director, Cancer Immunotherapeutics Center at UPMC Hillman Cancer Center. "The approval of pembrolizumab for the adjuvant treatment of patients 12 years and older with stage IIB and IIC melanoma following complete resection is an important advance that provides these patients with a new option that can help reduce the risk of their cancer returning."
"KEYTRUDA was the first anti-PD-1 therapy to be approved in metastatic melanoma in the U.S. seven years ago. Since then, we have built on this foundation in melanoma and have expanded the use of KEYTRUDA into earlier stages of this disease," said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. "With the approval, we can now offer healthcare providers and patients 12 years and older the opportunity to help prevent melanoma recurrence with KEYTRUDA across resected stage IIB, stage IIC and stage III melanoma."
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