J&J Gets Breakthrough Therapy Tag For Prostate Cancer Drug
Zacks Investment Research | Oct 03, 2019 10:31PM ET
Janssen, a subsidiary of Johnson & Johnson (NYSE:JNJ) , announced that the FDA has granted Breakthrough Therapy designation for PARP inhibitor, niraparib, for treating BRCA1/2 mutated metastatic castration resistant prostate cancer (mCRPC).
Please note that Janssen had entered into a collaboration and license agreement with TESARO, now part of GlaxoSmithKline (NYSE:GSK) , in 2016. This deal granted Janssen exclusive rights to niraparib in prostate cancer. Notably, niraparib is already approved as maintenance therapy in ovarian cancer patients, who have achieved complete or partial response to prior platinum-based chemotherapy. Glaxo markets niraparib for ovarian cancer under the tradename of Zejula.
FDA’s Breakthrough Therapy designation is granted to speed up the development and review of drugs that target serious or life-threatening conditions. The designation also indicates that Zejula can be eligible for accelerated approval and priority review depending upon certain criteria.
The designation was granted based on data from the phase II GALAHAD study, evaluating the candidate in patients previously treated with a taxane chemotherapy and androgen receptor-targeted therapy. Interim data presented at the European Society for Medical Oncology 2019 Annual Congress demonstrated that niraparib achieved an objective response rate of 41% in BRCA-mutant mCRPC patients.
So far this year, J&J’s stock has gained 1.6% against a 2.9% decline recorded by the label expansion of the drug, earlier this month, in metastatic castration-sensitive prostate cancer is likely to boost its sales going forward.
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