FDA approves niraparib regimen for metastatic castration-resistant prostate cancer
Click Here to Manage Email Alerts
Key takeaways:
- The FDA approved niraparib and abiraterone acetate with prednisone for BRCA-mutated castration-resistant prostate cancer.
- The regimen is approved for adults with deleterious or suspected deleterious mCRPC.
The FDA approved niraparib and abiraterone acetate with prednisone for the treatment of deleterious or suspected deleterious BRCA-mutated castration-resistant prostate cancer.
The approval is supported by efficacy data from the MAGNITUDE trial.
Researchers randomly assigned men with homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer to receive either niraparib 200 mg and abiraterone acetate (Akeega, Janssen Biotech, Inc.) plus 1,000 mg prednisone 10 mg or placebo and abiraterone acetate plus prednisone.
Results showed a statistically significant improvement in radiographic PFS for men with prospectively determined BRCA gene mutations who received niraparib and abiraterone acetate plus prednisone compared with those treated with placebo and abiraterone acetate plus prednisone.
The most common adverse reactions — including laboratory abnormalities — were decreased hemoglobin, lymphocytes, white blood cells, platelets, neutrophils or potassium, fatigue, musculoskeletal pain, constipation, hypertension, nausea and increased alkaline phosphatase, creatinine, potassium or AST.
The indication allows for the use Akeega in adults with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer, as determined by an FDA-approved test, according to an FDA press release.
“The recommended Akeega dose is 200 mg niraparib and 1,000 mg abiraterone acetate taken orally once daily in combination with 10 mg of prednisone daily until disease progression or unacceptable toxicity,” the FDA wrote in the release. “Patients receiving niraparib and abiraterone acetate plus prednisone should also receive a GnRH analog concurrently or should have had bilateral orchiectomy.”
Read more about
Click Here to Manage Email Alerts