This is the first and only dual action (or fixed-dose combination [FDC]) tablet combining a PARP inhibitor (niraparib) and a next-generation hormonal therapy (abiraterone acetate). Its ability to serve as a treatment for patients with deleterious or suspected deleterious BRCA-mutated, metastatic castration-resistant prostate cancer (mCRPC), should help to fulfill the need for more effective treatments. BRCA-positive mCPRC disease tends to be more aggressive; ~10-15% of patients with mCRPC harbor BRCA gene mutations. The approvals in both the United States and European Union represent the third prostate cancer treatment by Johnson & Johnson Innovative Medicine to reach this milestone and highlight the importance of reliable predictive biomarkers for precision treatment of patients. In August 2023, Foundation Medicine Inc received approval from the U.S. FDA for FoundationOne®CDx to be used as a companion diagnostic for niraparib + abiraterone acetate.
The development of niraparib + abiraterone acetate used an inventive and smart life cycle management strategy (especially considering generics are available for abiraterone). It has a competitive edge given the very good efficacy as well as the positive physician opinion and desire to prescribe it. As an FDC in a single tablet, it is a convenient alternative.
U.S. FDA and EMA approvals were based on the results of a large phase 3 clinical trial (MAGNITUDE) conducted with patients with mCRPC (with or without homologous recombination repair [HRR]-associated gene alterations) who received niraparib + abiraterone acetate plus prednisone, whose outcomes were compared with those of patients who received placebo + abiraterone plus prednisone. The findings included the following:
April 2022
February 2023
April 2023
For patients with BRCA-positive mCRPC, to be used in combination with prednisone
August 2023
For patients with deleterious or suspected deleterious BRCA-positive mCRPC, as detected by an FDA-approved test
Actual and expected launch:
How will niraparib + abiraterone acetate impact the market for prostate cancer?
What gaps in treatment does niraparib + abiraterone acetate fill?
When treated with current standard of care, mCRPC remains an incurable disease, and patients with BRCA-positive mCRPC are more likely to have aggressive disease, experience poor outcomes and have shorter survival times. Drugs with novel MOAs are needed to provide more effective treatment options. PARP inhibitors have the potential to partially satisfy this unmet need, and targeted therapies with predictive biomarkers will help ensure that patients are matched to the most effective MOA. Compared with earlier-to-market PARP + hormonal agent combinations for this molecularly defined subset of patients, niraparib + abiraterone acetate provides a convenient dosing schedule (once-daily dose).
What hurdles might it need to overcome to reach blockbuster status?
Niraparib + abiraterone acetate is likely to face stiff competition from other PARP inhibitor and hormone therapy combinations. Lynparza in combination with abiraterone acetate has the first-to-market advantage in the first line mCRPC with BRCA mutation segment. Lynparza also has greater physician familiarity due to its earlier approval as monotherapy in later-line settings. Another competitor, TALZENNA® (Pfizer Inc) in combination with XTANDI® (Pfizer Inc and Astellas Pharma Inc), has a broader label that also extends to patients with other HRR mutations. Additionally, some oncologists will prefer the dosing flexibility and cost saving offered by “open combinations” over FDCs.
– Source: Cortellis Competitive Intelligence, Drug Timeline & Success Rates Prediction current as of November 3, 2023
Access global intelligence, advanced analytics and global experts from Clarivate.