Johnson & Johnson said the U.S. Food and Drug Administration granted a breakthrough therapy designation to its cancer drug Zejula for the treatment of patients with a certain type of prostate cancer.
The company's unit Janssen Pharmaceuticals Inc. said Zejula, or niraparib, was granted the status to treat patients with BRCA1/2 gene-mutated metastatic castration-resistant prostate cancer, or mCRPC. This type of cancer keeps growing in patients even when testosterone in the body has been reduced to very low levels.
The designation is based on data from the phase 2 trial called Galahad. The company evaluated the efficacy and safety of the Zejula in patients with mCRPC and DNA-repair gene defects during the study.
The FDA grants a breakthrough designation to a new therapy that treats serious or life-threatening conditions and is potentially better than existing therapies. The breakthrough therapy designation will expedite the development and review of the drug in the mentioned indication.
Johnson & Johnson acquired exclusive rights for Zejula to treat prostate cancer globally, except in Japan, from Tesaro Inc. in April 2016. GlaxoSmithKline PLC acquired Zejula as part of its $5.1 billion takeover of Waltham, Mass.-based cancer drugmaker Tesaro.
Zejula is also being evaluated in a late-stage study to treat certain breast cancer patients and a mid-stage study in patients with ovarian cancer, as well as several combination studies in both breast and ovarian cancers.
The drug is approved by the U.S. regulator for maintenance treatment of women with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who had a complete or partial response to platinum-based chemotherapy.
