Merck’s anti-PD-1 therapy, Keytruda, has obtained approval from the US Food and Drug Administration (FDA) as an adjuvant therapy for stage IIB or IIC melanoma patients aged 12 years and above.
The FDA also expanded the therapy’s indication as adjuvant treatment for stage III melanoma following complete resection to include 12 years and above aged paediatric patients.
An anti-programmed death receptor-1 (PD-1) therapy, Keytruda works by blocking the interaction between PD-1 with its ligands, PD-L1 and PD-L2, to activate T lymphocytes.
The approval was based on the results obtained from the Phase III KEYNOTE-716 trial’s first interim analysis.
The double-blind, multicentre, randomised, placebo-controlled study was conducted on 976 participants with completely resected stage IIB or IIC melanoma.
This showed that Keytruda reduced disease recurrence or death risk by 35% and improved recurrence-free survival (RFS) compared to placebo.
Merck Research Laboratories clinical research vice-president Dr Scot Ebbinghaus said: “Keytruda was the first anti-PD-1 therapy to be approved in metastatic melanoma in the US 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.
“With today’s 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.”
The company claimed that the therapy is the first of its kind to show recurrence-free survival (RFS) benefits in the adjuvant setting for patients suffering with stage IIB and IIC melanoma.
Last month, Merck received German, Austrian competition authorities’ approval to acquire clinical-stage biopharmaceutical firm Acceleron Pharma.