Johnson & Johnson’s idea to carve out the prostate cancer indication from GSK’s PARP inhibitor Zejula has yielded its first global approval.

Following a recommendation from the European Medicines Agency, the European Commission has officially approved J&J’s Akeega in metastatic castration-resistant prostate cancer (mCRPC), J&J said Friday. The drug is a fixed-dose combo of Zejula and J&J’s androgen-directed Zytiga, and it’s used alongside a corticosteroid.

Under a 2016 deal with Zejula’s developer Tesaro, J&J specifically carved out rights to the drug in prostate cancer. GSK then bought out Tesaro in 2019.

Not all patients can get Akeega under the drug’s European label. To be eligible, a patient’s tumor must test positive for BRCA1/2 mutations, which account for 10% to 15% of all cases, J&J said.

Akeega’s label in Europe is narrower than that of rival PARP inhibitor Lynparza from AstraZeneca and Merck. The European Commission in December cleared Lynparza and Zytiga for mCRPC with no restrictions on tumor mutation status.

Akeega got the narrow indication despite showing a tumor progression benefit in a larger group of patients with various mutations in homologous recombination repair (HRR) genes.

Reference: https://www.fiercepharma.com/pharma/jj-gains-parp-drugs-first-nod-prostate-cancer-astrazeneca-gears-fda-checkpoint