Merck gets FDA nod for Keytruda as adjuvant treatment for melanoma

Source: Pharmaceutical Business Review, March 2019

Merck has secured approval from the US Food and Drug Administration (FDA) for its Keytruda (pembrolizumab) as the adjuvant treatment for patients with melanoma with involvement of lymph node(s) following complete resection.

The recommended dose of Keytruda for the adjuvant treatment of adult patients with melanoma is 200 mg administered as an intravenous infusion over 30 minutes every three weeks until disease recurrence, unacceptable toxicity, or for up to 12 months in patients without disease recurrence.

The approval was based on data from the EORTC1325/ Keynote-054 trial, which was carried out in collaboration with the European Organisation for Research and Treatment of Cancer (EORTC).