- The Food and Drug Administration on Friday approved a new medicine for prostate cancer, clearing Johnson & Johnson’s Akeega for use in certain patients newly diagnosed with advanced disease.
- The drug is a pill that combines niraparib — a medicine currently sold by GSK as Zejula — and J&J’s prostate cancer treatment Zytiga. J&J licensed use of niraparib in prostate cancer before GSK acquired the drug’s original owner, Tesaro, in 2019.
- The agency greenlighted Akeega for use alongside the steroid prednisone in the estimated 10% to 15% of prostate cancer patients with suspected BRCA mutations. The narrow label is similar in scope to what the FDA granted this year to two other, similar drugs known as “PARP” inhibitors because of the DNA-protecting enzyme they target.
Approval of Akeega follows U.S. clearances in the same setting for Merck and AstraZeneca’s Lynparza and Pfizer’s Talzenna. Collectively, they represent new ground for PARP blockers, which were previously only available for prostate cancer patients whose disease progressed after one or two commonly-used therapies.
Yet, the market opportunity is lower than drugmakers once envisioned. The FDA approved Lynparza and Talzenna only in a narrow subgroup of patients due to concerns about their safety and effectiveness in the broader population. Though European regulators took a different view and approved wider Lynparza use, the stricter standards in the U.S. have led analysts to significantly lower their sales projections for PARP blockers in prostate cancer.
And in April, J&J received a more limited clearance in Europe than it had sought. The company tested Akeega in patients with a variety of different genetic alterations who hadn’t received a prior therapy — or, at most, up to four months of Zytiga and a steroid — and reported a benefit in the overall group.
However, the benefit was driven by BRCA-positive patients, who often have faster-moving cancers and poorer health outcomes. In that group, treatment was associated with a 47% reduction in the risk of disease progression after a median of just over two years. European drug regulators approved Akeega only for those patients.
The FDA on Friday issued a similar decision, meaning J&J will now compete with Talzenna and Lynparza for smaller market share. The company noted how Akeega is the “first-and-only dual action” tablet, as the drug combines a PARP inhibitor with a commonly used hormone therapy, Zytiga. By comparison, Talzenna and Lynparza are both taken alongside hormone drugs.
Patients must get a confirmed BRCA diagnosis via an FDA-approved genetic test to be eligible for treatment. The most common serious side effects associated with Akeega in testing were pain, fatigue, constipation, high blood pressure and nausea. About 15% of patients who received treatment left the study because of an adverse reaction.