Johnson & Johnson (JNJ) said Friday the European medicines regulator's Committee for Medicinal Products for Human Use recommended extending approval of its Akeega treatment for patients with a specific form of metastatic prostate cancer.
The recommendation from CHMP backed the use of Akeega in combination with other therapies for adults with metastatic hormone-sensitive prostate cancer whose tumors carry BRCA1/2 genetic mutations.
Results from a late-stage trial showed the treatment reduced the risk of radiographic disease progression or death by 48% in patients with BRCA mutations.
The trial also showed a significant delay in the time to symptom progression and an early trend toward improved overall survival, the company added.
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