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Merck Secures Canadian Regulatory Nod For KEYTRUDA In Skin Cancer After Resection

Health Canada has granted approval for Merck’s (NYSE: MRK) KEYTRUDA (pembrolizumab) for the adjuvant treatment of adult and pediatric (12 years and older) patients with stage IIB or IIC melanoma following complete resection. 

Benzinga · 09/13/2022 11:19

Health Canada has granted approval for Merck’s (NYSE:MRK) KEYTRUDA (pembrolizumab) for the adjuvant treatment of adult and pediatric (12 years and older) patients with stage IIB or IIC melanoma following complete resection. 

The regulatory approval is based on the data readout from the Phase 3 KEYNOTE-716 trial, which demonstrated a statistically significant improvement in recurrence-free survival (RFS).

The results of KEYNOTE-716 demonstrated a statistically significant improvement in RFS for patients randomized to receive KEYTRUDA compared with patients randomized to placebo at the first pre-specified interim analysis.

During the study period, the safety profile of KEYTRUDA was consistent with previously reported studies in patients with solid tumors.

Marwan Akar, President, and Managing Director, Merck Canada, stated, ”This approval is important for people living with melanoma and for all of us at Merck. With this new indication, KEYTRUDA is the first checkpoint inhibitor approved in Canada in the adjuvant space in Stage IIB or IIC melanoma, meaning it can be considered for patients earlier in their journey. We are proud to continue to pursue our passion to save and improve lives as well as reinforce our commitment to finding innovative and effective options for more patients with melanoma.”

Melanoma is a form of skin cancer that starts in the melanocyte cells of the skin. Although less common than other forms of skin cancer, melanoma is the most serious type.

Price Action : Merck shares are trading around 1 percent down at $87.11 on Tuesday at the time of publication.