Following FDA approvals for fellow PARP inhibitors made by AstraZeneca/Merck and Pfizer, Johnson & Johnson has got its own combo approval in prostate cancer.
The tablet treatment, known commercially as Akeega, combines J&J’s androgen-directed Zytiga (abiraterone acetate) and the PARP inhibitor niraparib, which is sold by GSK as Zejula in other indications. The FDA has signed off on its use along with the corticosteroid prednisone, but only in a subset of mCRPC patients—those with BRCA mutations.
Akeega will compete with AstraZeneca and Merck’s Lynparza as well as Pfizer’s Talzenna in the indication. Eleven weeks ago, the FDA gave Lynparza the same narrow label for those with the BRCA-positive tumors. Talzenna’s approval covers a broader population, including other mutations in the homologous recombination deficiency family.
Under a 2016 deal with Zejula’s developer Tesaro, J&J carved out rights to the drug in prostate cancer. GSK then bought out Tesaro in 2019.
The FDA’s Akeega nod was based on results of the MAGNITUDE phase 3 study, which showed the combo reduced the risk of radiographic disease progression or death by 47% in BRCA-mutant disease, compared to placebo plus Zytiga plus prednisone.
At the second interim analysis, with median follow-up at 24.8 months in the BRCA-positive subgroup, Akeega plus prednisone showed a median radiographic progression-free survival of 19.5 months compared with 10.9 months for the placebo group.
The observed safety profile of the combination was consistent with the known safety profile of each of the monotherapies, J&J said.
“This milestone, which marks the approval of Janssen’s third prostate cancer treatment, highlights the importance of advancing precision medicine approaches and genetic testing for the treatment of patients with BRCA-positive mCRPC,” Kiran Patel, M.D., Janssen’s VP of clinical development, solid tumors, said in a release.
Prostate cancer is one of the most common cancers in the U.S., with an estimated 288,300 new cases and nearly 35,000 deaths expected this year. Patients with BRCA-positive mCRPC are more likely to have aggressive disease and may experience poor outcomes and a shorter survival time.