Johnson & Johnson group Janssen Research & Development said US regulators are undertaking an accelerated review of Yondelis (trabectedin) to treat patients with advanced soft tissue sarcoma.
The US Food and Drug Administration’s priority review will assess the drug in STS, including liposarcoma and leiomyosarcoma subtypes, in patients who have received prior chemotherapy including an anthracycline.
This means Janssen can expect an FDA action date within six-months as opposed to the standard 10-month time-frame, and indicates that the regulator believes Yondelis could offer major advances in treatment compared to existing options.
Soft tissue sarcomas originate in the soft tissues that connect, support and surround other body structures, such as muscle, fat, blood vessels, nerves, tendons and the lining of joints. In the US, nearly 12,000 people will be diagnosed and around 4,870 are expected to die of soft tissue sarcomas this year.
Yondelis is a novel, multimodal, synthetically-produced anti-tumour agent, originally derived from the sea squirt, Ecteinascidia turbinata, which is approved in 77 countries for advanced STS as a single-agent and in 70 countries for relapsed ovarian cancer in combination with Doxil/Caelyx (doxorubicin HCl liposome injection).
Under a licensing deal with PharmaMar, a wholly owned member of the Zeltia Group, Janssen has rights to develop and sell the drug globally except in Europe, where PharmaMar SA holds the rights, and in Japan, where Taiho Pharmaceuticals hold a license.