FDA grants J&J’s niraparib BTD for prostate cancer

Johnson & Johnson’s PARP inhibitor niraparib has been given a breakthrough therapy designation` by the FDA in patients with BRCA1/2 gene-mutated, metastatic castration-resistant prostate cancer. Patients must have received prior taxane chemotherapy and androgen receptor-targeted therapy prior to beginning niraparib treatment. The approval came on the back of results from the phase 2 GALAHAD study where niraparib demonstrated a 41% objective response rate in BRCA patients, and a median duration of object response of 5.5 months. The median radiographic progression-free survival and overall survival in BRCA patients was 8.2 and 12.6 months respectively.
Niraparib is also marketed in the US by GSK as Zejula, and is indicated for the treatment of ovarian, fallopian and primary peritoneal cancer.
Kiran Patel, vice president, clinical development, solid tumours at Janssen Research & Development, said: “We are pleased with the FDA’s Breakthrough Therapy Designation as we continue the clinical development of niraparib, and we look forward to working with the agency in our continued focus and commitment to bring new advancements to patients diagnosed with prostate cancer.”