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Johnson & Johnson win FDA Breakthrough status for cancer drug Zejula

Published on 07/10/19 at 05:05pm

The US FDA has granted breakthrough therapy designation for Johnson & Johnson’s Zejula (niraparib) for the treatment of metastic prostate cancer, who have previously received hormone treatments and chemotherapy and who also have mutations in the BRCA1 and BRCA2 genes.

The agency gave the designation based on Phase 2 data presented at this year’s European Society for Medical Oncology (ESMO) earlier last week.

According to the data released at ESMO, 41% of prostate cancer patients in the trial who had BRCA mutations responded to Zejula.

The breakthrough tag will no doubt speed up the FDA’s review of Zejula which is currently marketed by GlaxoSmithKline’s Tesaro unit to treat ovarian, fallopian tube or primary peritoneal cancer. Johnson & Johnson licensed the exclusive rights to develop and market the drug in prostate cancer in 2016.

Kiran Patel, Vice President of Clinical Development at Janssen, said: “Niraparib is a PARP inhibitor that we believe may help address an important unmet need for patients with metastic castration resistant prostate cancer who have mutations in DNA-repair genes.

“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.”

Nik Kiran

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