EU CHMP recommends approval of Keytruda for adjuvant treatment of stage IIB or IIC melanoma.- Merck Inc
Merck Inc announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of Keytruda (pembrolizumab) as monotherapy for the adjuvant treatment of adults and adolescents aged 12 years and older with stage IIB or IIC melanoma and who have undergone complete resection.
Additionally, the CHMP recommended expanding the indications for Keytruda in advanced (unresectable or metastatic) melanoma and stage III melanoma (as adjuvant treatment following complete resection) to include adolescent patients aged 12 years and older.
The positive opinion was granted based on results from the Phase III KEYNOTE-716 trial, which demonstrated a statistically significant improvement in recurrence-free survival with Keytruda compared to placebo (HR=0.65 [95% CI, 0.46-0.92]; p=0. 0.00658) in patients 12 years and older with stage IIB and IIC melanoma following complete resection. Earlier this year, Merck reported that KEYNOTE-716 also met its key secondary endpoint of distant metastasis-free survival. These results will be featured in a late-breaking oral presentation at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting on June 5 (Abstract #LBA9500).
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