EU CHMP approves Merck’s KEYTRUDA as Adjuvant Treatment for patients (≥12 Years) With Stage IIB or IIC Melanoma Following Complete Resection

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Merck, today, announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, 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.

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.

“Based on the results of the KEYNOTE-716 trial, KEYTRUDA has shown a significant improvement in recurrence-free survival and distant metastasis-free survival for these patients with resected stage IIB or IIC melanoma,” 

Dr. Scot Ebbinghaus, vice president, global clinical development, Merck Research Laboratories

“The CHMP’s positive recommendation brings us one step closer to providing patients 12 years and older in the European Union with a new option for resected stage IIB or IIC melanoma that can reduce the risk of their cancer returning.” added Dr. Scot.

The positive opinion was granted based on results from the Phase 3 trial (named as KEYNOTE-716) that demonstrated a statistically significant improvement in recurrence-free survival with KEYTRUDA 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. The company will feature the results in a late-breaking oral presentation at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting on June 5.

Merck stated, ‘The CHMP’s recommendation will now be reviewed by the European Commission for marketing authorization in the European Union, and a final decision is expected in the second or third quarter of 2022.’

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