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FDA approves Yonsa for metastatic castration-resistant prostate cancer
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The FDA approved a novel formulation of abiraterone acetate in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer, according to the agent’s manufacturers.
Yonsa (Sun Pharma, Churchill Pharmaceuticals) is a CYP17 inhibitor which uses SoluMatrix Fine Particle Technology (Iroko Pharmaceuticals) to create a smaller particle size formulation of abiraterone acetate tablets.
“We are pleased to add Yonsa to our growing oncology portfolio and continue to deliver on Sun Pharma’s commitment for enhanced patient access to innovative cancer therapies,” Abhay Gandhi, North America’s CEO of Sun Pharma, said in a press release.
The most common adverse reactions associated with abiraterone acetate included fatigue, joint swelling or discomfort, edema, hot flush, diarrhea, vomiting, cough, hypertension, dyspnea, urinary tract infection and contusion. The most common laboratory abnormalities included anemia, elevated alkaline phosphatase, hypertriglyceridemia, lymphopenia, hypercholesterolemia, hyperglycemia, elevated aspartate transaminase, hypophosphatemia, elevated alanine aminotransferase and hypokalemia.