PharmaMar’s partner, Merck, has submitted a New Drug Application in Japan for Zepzelca® (lurbinectedin) regarding first line maintenance therapy in small cell lung cancer

PharmaMar (MSE: PHM), has announced that Merck (MRK.DE) has submitted a marketing application to Japan’s Ministry of Health, Labour and Welfare (MHLW) for Zepzelca® (lurbinectedin) regarding the first line maintenance treatment of small cell lung cancer (SCLC). Merck´s New Drug Application (NDA) was granted priority review. In April 2025, PharmaMar and Merck announced an exclusive licensing agreement for the development and commercialization in Japan of lurbinectedin for the treatment of SCLC. In addition, on March 19th, 2026, Japan’s MHLW designated lurbinectedin as an orphan drug, a category granted to drugs intended for the treatment of diseases affecting fewer than 50,000 patients and for which there is a particularly high unmet medical need. Lurbinectedin in combination with atezolizumab has already been approved in Europe and in 14 other countries, including the United States, for first-line maintenance treatment of this disease.

The release as fetched from its publisher. pharmamar.com ↗