Europe was first in the world to approve a single tablet that pairs a PARP inhibitor with abiraterone for prostate cancer. The European Commission authorized Akeega, a dual action tablet of niraparib and abiraterone acetate, in April 2023, with OncLive and Urology Times reporting it on April 24.
It is meant to be taken with prednisone or prednisolone by adults with metastatic castration-resistant prostate cancer who carry BRCA1/2 mutations and when chemotherapy is not a clinical option. Niraparib is sold separately as Zejula and abiraterone as Zytiga.
Evidence from MAGNITUDE
The authorization draws on MAGNITUDE, a phase 3 study that screened men for alterations in homologous recombination repair genes, among them BRCA1 and BRCA2. Of the patients, 212 got niraparib plus abiraterone and prednisone and 211 got abiraterone and prednisone alone.
Across everyone with a repair-gene alteration, the niraparib arm cut the risk of radiographic progression or death by 27% at a median follow-up of 16.7 months. Median radiographic progression-free survival was 16.5 months against 13.7 months.
The gain was sharper in men with BRCA1/2 mutations. There the risk fell by 47% (hazard ratio 0.53), and median radiographic progression-free survival was 16.6 months versus 10.9 months. After roughly 8 more months of follow-up the gap held: 19.5 months with niraparib and 10.9 months without. In this group the added drug also pushed back symptomatic progression and the start of cytotoxic chemotherapy. Overall survival leaned in its favor too, though not by a margin that settled the question.
“mCRPC remains a lethal disease, with high unmet needs in terms of treatment options, particularly for patients with BRCA1/2 gene mutations,” said Professor Gerhardt Attard, an oncologist at University College London. He called the tablet “a promising first-line targeted treatment option” for these men.
Patients in the trial could have had up to 4 months of abiraterone for their castration-resistant disease, scored 0 or 1 on the ECOG performance scale, and reported worst pain of no more than 3 on the Brief Pain Inventory-Short Form.
Sources
- Niraparib/Abiraterone Acetate Combo Approved in Europe for BRCA1/2+ mCRPC (OncLive)
- Niraparib/abiraterone tablet approved in EU for BRCA+ mCRPC (Urology Times)
