AstraZeneca (AZN) said Friday the US Food and Drug Administration approved Truqap in combination with abiraterone and prednisone for adults with PTEN-deficient metastatic androgen pathway modulation-naive or sensitive prostate cancer.
The approval targets about 35,000 patients annually in the US, where roughly one in four carry PTEN-deficient tumours, the company said.
AstraZeneca said the decision was based on a phase 3 trial, which showed the combination reduced the risk of radiographic disease progression or death by 19% and extended median progression-free survival to 33.2 months versus 25.7 months for standard treatment.
The most common grade 3 or higher side effects, occurring in 67% of patients, included rash and elevated blood sugar levels, the company said.
The FDA also approved a companion diagnostic test to identify eligible patients, while a regulatory review is ongoing in the European Union.
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