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Johnson & Johnson Unit Submits EMA Application to Extend Indication of Akeega for Prostate Cancer
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Johnson & Johnson Unit Submits EMA Application to Extend Indication of Akeega for Prostate Cancer
Jul 3, 2025 6:45 AM

09:25 AM EDT, 07/03/2025 (MT Newswires) -- Johnson & Johnson's ( JNJ ) Janssen-Cilag International unit said Thursday it submitted an extension of indication application to the European Medicines Agency seeking approval of Akeega for treating adult patients with metastatic hormone-sensitive prostate cancer and homologous recombination repair gene alterations.

The submission was based on a phase 3 study that showed "clinically meaningful and statistically significant" outcomes in the primary endpoint of radiographic progression-free survival, the company said.

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