J&J's Prostate Cancer Drug Gets FDA Nod for Expanded Use

Johnson & Johnson JNJ announced that the FDA has granted approval to its new prostate cancer drug Erleada for an expanded patient population.

With the latest approval, Erleada can now be prescribed to treat patients with metastatic castration-sensitive prostate cancer (mCSPC) also known as metastatic hormone-sensitive prostate cancer. Erleada, a next-generation oral androgen receptor inhibitor, is already marketed in the United States for the treatment of men with non-metastatic castration-resistant prostate cancer (nmCRPC).

J&J estimates that annually 40,000 people in the United States are diagnosed with mCSPC, a type of prostate cancer, which has spread to other parts of the body. This can now be treated with Erleada

The supplemental new drug application (sNDA)was based on data from the phase III TITAN study. Data from the study showed that Erleada plus androgen deprivation therapy (ADT) significantly improved the dual primary endpoints of overall survival (OS) and radiographic progression-free survival (rPFS) in such patients. Erleada plus ADT led to a 33% reduction in the risk of death, thereby significantly extending OS. Erleada plus ADT also led to a 52% reduction in risk of radiographic progression or death, thereby showing a significant improvement in rPFS. A similar label expansion application is also under review in the EU with a decision expected soon.

J&J’s stock has risen 1% this year so far against a decrease of 1.7% recorded by the industry.

Erleada was added to J&J’s portfolio through the August 2012 Aragon acquisition and was launched for treating nmCRPC in 2018. The drug is off to a strong start with sales expected to go up with the latest FDA approval for mCSPC patients.

Also, Erleada’s approval has strengthened J&J’s prostate cancer franchise, especially as generic versions of J&J’s blockbuster prostate cancer drug, Zytiga have been launched.  Companies like Dr Reddy’s RDY, Apotex, Mylan MYL ), Teva TEVA, Amneal Pharmaceuticals, Par Pharmaceutical and Hikma Pharmaceuticals have all made generic version of Zytiga and a few of them have launched them too.

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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