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J&J Gets Breakthrough Therapy Tag for Prostate Cancer Drug

Zacks Equity Research

Janssen, a subsidiary of Johnson & Johnson 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 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 industry.

Other PARP inhibitors like – AstraZeneca/Merck’s Lynparza, Clovis Oncology’s CLVS Rubraca and Pfizer’s PFE Talzenna – are also being developed as a potential treatment options for prostate cancer including mCRPC. Lynparza and Rubraca are approved as second-line maintenance treatments for ovarian cancer and competes with Zejula in the ovarian cancer segment.

J&J already has two FDA approved prostate cancer drugs – Zytiga and Erleada – in its commercial portfolio. We note that the blockbuster drug, Zytiga, has started to face generic competition that has impacted its sales significantly in the first half of 2019. The launch of Erleada last year for non-metastatic CRPC is bringing additional sales, however, small. A 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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J&J currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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