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J&J secures key US FDA approval for prostate cancer drug Erleada

Johnson & Johnson's Janssen Pharmaceuticals Inc. unit has secured an additional U.S. Food and Drug Administration approval for prostate cancer drug Erleada, providing a boost for the pharmaceutical giant that is facing pressure from generic drug competition.

Also known as apalutamide, Erleada is already approved to treat patients with non-metastatic castration-resistant prostate cancer, a type of cancer that has not yet spread to other parts of the body but is resistant to hormone therapy. The U.S. regulator has now extended the therapy's use to metastatic castration-sensitive prostate cancer, a type that has spread to other parts of the body despite responding to hormone therapy, according to a Sept. 17 press release.

Metastatic castration-sensitive prostate cancer is typically treated with androgen deprivation therapy, which aims to lower testosterone levels in men with the disease. Erleada will be added to this course of treatment under the new FDA approval.

The FDA had previously granted priority-review status to Erleada for this indication, allowing for an accelerated review period. The drug was submitted to the regulator in April.

SNL ImageJohnson & Johnson's Janssen Pharmaceuticals unit has received another approval for prostate cancer drug Erleada.
Source: Johnson & Johnson

The approval was based on a phase 3 clinical trial called Titan, which showed that the therapy along with standard hormone therapy improved the overall survival of patients and extended the time that patients survived without their disease progressing. Results from that study were presented at the American Society of Clinical Oncology meeting in June.

J&J said 40,000 people are diagnosed with metastatic castration-sensitive prostate cancer every year in the U.S. One of the study's investigators noted that prostate cancer is much more difficult to treat once it spreads to other parts of the body, and the disease is not adequately controlled with the standard of care treatment that is available.

Cowen analysts said in a Sept. 18 note that the new Erleada approval will provide Janssen with another offset to pressure from generics competition seen across the company's portfolio. Cowen's Joshua Jennings and Harris Iqbal said Janssen's pharma business is expected to slow in 2019, but will pick back up again in 2020 — with the new Erleada approval providing a boost. Growth for Janssen is expected particularly in oncology.

J&J has been confident in the success of Erleada, and executives stated on the second quarter earnings call that the therapy saw a 3.5% increase in market share in the non-metastatic castration-resistant prostate cancer market.

Cowen said J&J has several other opportunities for Erleada in the pipeline, including a combination trial with the company's other prostate cancer drug Zytiga in metastatic castrate-resistant prostate cancer. Erleada is also being studied to be used in patients earlier in the course of their prostate cancer treatment.