Johnson & Johnson secures FDA’s breakthrough therapy designation therapy with prostate cancer drug


The FDA approved J&Js PARP inhibitor niraparib, a breakthrough therapy designation (BTD) in prostate cancer, helping it to make gains on rival Lynparza.

J&Js subsidiary Janssen has exclusive rights to the inhibitor, which is currently marketed in the US by GSK under the name of Zejula with indications for the treatment of ovarian, fallopian and primary peritoneal cancer. Janssen achieved its hope to expand the inhibitors reach with this fast-tracking approval for patients with prostate cancer. To use the inhibitor patients must have received prior taxane chemotherapy and androgen receptor (AR)- targeted therapy prior to beginning niraparib treatment.

The results from the phase two GALAHAD study showed that niraparib demonstrated a 41% objective response rate in patients and a median duration response rate of 5.5 months. These results will surely help Janssen to challenge rivals AZ/Merck’s PARP inhibitor Lynparza, which has also demonstrated positive results in prostate cancer patients of the same indication. However, at the moment Lynparza is ahead of Janssen as it is currently in the third phase of its clinical trials, as well as being studied in patients with a variety of mutations in the HRRm genes for prostate cancer.

Further advantages of AZ/Merck over J&J is that Merck’s blockbuster Keytruda is currently being studied in patients with prostate cancer as well as being studied in combination with Lynparza which could give AZ/Merck a real competitive edge over J&J if positive results seen.

From a bigger picture this news presents exciting news for prostate cancer treatments, as the emergence of these PARP inhibitors signifies a potential of unlocking a whole new stream of treatment pathways for a select patient population.

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