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J&J bags FDA breakthrough designation for prostate cancer drug

Could challenge rival PARP inhibitor Lynparza


The FDA has granted Johnson & Johnson's PARP inhibitor niraparib a breakthrough therapy designation (BTD) in prostate cancer, helping it to make gains on rival Lynparza. 

J&J’s pharmaceutical division Janssen has exclusive rights to niraparib in prostate cancer. The drug is also marketed as Zejula in the US by GlaxoSmithKline, and is indicated for the treatment of ovarian, fallopian and primary peritoneal cancer.

Janssen is looking to expand the PARP inhibitor’s reach, with this BTD fast-tracking an approval in patients with BRCA1/2 gene-mutated, metastatic castration-resistant prostate cancer (mCRPC). Patients must have received prior taxane chemotherapy and androgen receptor (AR)-targeted therapy prior to beginning niraparib treatment.

Mutations in the BRCA1/2 genes are the most common defects in patients with mCRPC. The BTD is based on data from Janssen’s phase 2 GALAHAD study – the results of which were recently presented at the European Society for Medical Oncology (ESMO).

The interim results from that study showed that 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.

“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,” said Kiran Patel, vice president, clinical development, solid tumours at Janssen Research & Development.

These results could help Janssen to challenge AstraZeneca/Merck & Co’s rival PARP inhibitor Lynparza (olaparib), which also presented positive results prostate cancer patients in the same indication. However, Lynparza is slightly ahead of niraparib in this respect, as it is already currently being studied in phase 3 and in prostate cancer patients with mutations in a number of homologous recombination repair (HRRm) genes – including BRCA 1, BRCA 2, ATM and 11 others.

Either way, the emergence of these new PARP inhibitors holds a particular significance in prostate cancer, holding the promise of unlocking new targeted treatment pathways for a select patient population.

Also looking to enter the prostate cancer area is Merck & Co’s blockbuster PD-1 inhibitor Keytruda, which is currently being studied in patients with mCRPC. It is also being studied in combination with Lynparza, which could give AZ/Merck & Co a competitive edge if it can demonstrate positive data in these trials.

Article by
Lucy Parsons

4th October 2019

From: Regulatory



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