Johnson & Johnson’s Janssen-Cilag unit gets disappointing ‘restricted’ label for PARP drug in EU

pharmafile | February 28, 2023 | News story | Medical Communications  

Johnson & Johnson (J&J)’s Janssen-Cilag unit has announced that its fixed-dose combination drug Akeega has been recommended for approval by the EMA’s Committee for Medicinal Products for Human Use (CHMP) for patients with metastatic castration-resistant prostate cancer (mCRPC), but that it should be limited to patients with BRCA1/2 mutations. This will put Akeega at a significant disadvantage compared to AstraZeneca and Merck’s rival PARP inhibitor Lynparza (olaparib).


Akeega is a combination of J&J’s PARP drug Zejula (niraparib) and androgen inhibitor Zytiga (abiraterone acetate). In December 2022, AstraZeneca and Merck claimed EU approval for the combination of Lynparza with Zytiga in an all-comer mCRPC patients, which allowed the regimen to be used without the need for mutations testing.


The CHMP recommendation comes after the phase 2 MAGNITUDE trial of Akeega. The data showed that the addition of Zejula to Zytiga plus prednisone or prednisolone significantly improved radiographic progression-free survival (rPFS) by 45%, compared to standard of care in untreated mCRPC patients with BRCA1/2 mutations.


Updated results from MAGNITUDE showed a trend towards improved overall survival but no significant effect of the drug combination in mCRPC patients without homologous recombination repair (HRR) mutations, half of which is accounted for by BRCA.


Martin Vogel, Janssen-Cilag’s head of oncology for the EMEA region stated: “In recent years, we’ve focused on precision medicine in prostate cancer because we know patients with gene mutations, such as BRCA1/2, face a worse prognosis than those without. The positive CHMP opinion reinforces the benefit of this niraparib combination and marks an important milestone in addressing BRCA1/2 mutations as we continue to drive progress towards changing the outlook for patients with mCRPC.”


James Spargo

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