NDA submitted for new formulation of mCRPC agent
Churchill Pharmaceuticals, LLC has submitted a new drug application to the FDA for abiraterone acetate (YONSA). YONSA is an improved ultramicrosize formulation of abiraterone to treat metastatic castration-resistant prostate cancer in combination with methylprednisolone, the company said. The NDA submission is based on the final results of the STAAR Study, a randomized, open-label trial that compared YONSA plus methylprednisolone, to Zytiga, another abiraterone formulation, plus prednisone in metastatic castration-resistant prostate cancer patients. A previous study of healthy volunteers also found that a 500-mg dose of Yonsa was found to be bioequivalent to a 1,000-mg dose of Zytga.
Partnership formed to conduct study of RCC treatment
Xynomic Pharma and the University of California, San Francisco (UCSF) have formed a strategic partnership to conduct PAX Study, a multinational, multicenter, randomized phase II/III study comparing pazopanib plus abexinostat against pazopanib monotherapy in patients with locally advanced or metastatic renal cell carcinoma. The study will be led by UCSF and will use data from a completed phase Ib study of pazopanib and abexinostat. The phase Ib study gathered data from 51 heavily pre-treated patients with metastatic solid tumors who were treated with pazopanib and abexinostat. Researchers observed durable tumor regressions in 70% of patients with pazopanib-refractory disease. Both Xynomic and UCSF view the partnership as a way to help accelerate the timeline for abexinostat for development and to ultimately receive regulatory approval in the U.S. and elsewhere.