FDA

J&J takes another big step forward with next-gen prostate cancer blockbuster apalutamide

J&J needs a big win from its pharma R&D group. And now it’s taking its shot.

Over the last year, J&J and Pfizer have been battling it out to expand the market for their rival prostate cancer drugs Zytiga and Xtandi, offering data that could expand their reach into new patient groups. But J&J has now taken an even bigger move: filing for an approval of apalutamide with the FDA for non-metastatic, castration-resistant prostate cancer.

Anyone following the field closely will recall that J&J spent $650 million in cash and offered another $350 million in milestones to bag Rich Heyman’s Aragon in 2013, just so it could have this drug. After largely staying quiet for a few years as they directed the therapy into their Phase III SPARTAN study, J&J has recently begun talking this drug up as a near-term blockbuster-to-be. And if they win an approval, J&J believes it has another big earner it can add to its cancer portfolio at a time the pharma giant has been struggling to prove it can generate more pharma cash.

Peter Lebowitz

Apalutamide (ARN-509) finished the Phase III SPARTAN study in June, but we don’t know the data for this next-gen oral therapy that blocks androgen from binding to the androgen receptor — preventing testosterone from fueling the disease. In a statement on Wednesday, J&J said that it plans to release the results at an upcoming scientific conference. But whatever it was, the data must have been good enough to pitch to regulators.

An approval here would position J&J to go into prostate cancer patients at an earlier stage, a key to expanding its franchise revenue.

Zytiga and Xtandi have been game-changers in treating advanced prostate cancer, changing the standard of care for patients. And now J&J believes it can take another big step in the same direction — with billions on the line.

“We have demonstrated that treating patients before the disease has metastasized improves outcomes,” said J&J oncology chief Peter Lebowitz in a statement. “We are thrilled to have completed our submission of the SPARTAN data to the FDA and we look forward to a promising treatment that can provide new hope and expectations for men facing this disease.”


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