J&J Wins FDA Nod for Erleada, the First Drug for Nonmetastatic Prostate Cancer

Janssen Pharmaceuticals got a little love from the U.S. Food and Drug Administration on Wednesday. The love wasn’t in the form of cupid’s arrow, instead it was the approval of Erleada, the first FDA-approved treatment for patients with non-metastatic castration-resistant prostate cancer (NM-CRPC).

The FDA’s approval came well ahead of the April PDUFA date thanks in part to a priority review that was based on the Phase III Spartan study. In that trial Erleada, an androgen receptor (AR) inhibitor, demonstrated a 72 percent reduction in risk of distant metastasis or death. Trial data also shows an increase in median metastasis-free survival (MFS) by more than two years. 24.31 months, in patients with NM-CRPC who were on the Erleada (Apalutamide) arm. The median MFS was 40.51 months for Erleada compared to 16.20 months for placebo, Janssen data shows.

Prostate cancer is the second most common cancer in men worldwide, with about 164,000 expected diagnoses in the United States this year. Castration-resistant prostate cancer refers to the subset of men whose prostate cancer progresses despite castration levels of testosterone. Non-metastatic castration-resistant prostate cancer refers to a disease state when the cancer no longer responds to medical or surgical treatments that lower testosterone but has not yet been discovered in other parts of the body. Prostate cancer is the second most common form of cancer in men in the U.S.  Ninety percent of patients with CRPC will eventually develop bone metastases, which can lead to pain, fractures and spinal cord compression. The relative 5-year survival rate for patients with distant stage prostate cancer is 30 percent.

Erleada works by blocking the effect of androgens, a type of hormone, on the tumor. These androgens, such as testosterone, can promote tumor growth, the FDA said in its announcement.

Richard Pazdur, director of the FDA’s Oncology Center of Excellence, said the FDA’s approval is “the first to use the endpoint of metastasis-free survival, measuring the length of time that tumors did not spread to other parts of the body or that death occurred after starting treatment.”

Mathai Mammen, global head of Janssen Research and Development, said the need to delay metastasis is critical in the treatment of prostate cancer. With the data showing nine of 10 patients with castration-resistant prostate cancer eventually developing metastases, Mammen said at that point patient prognosis worsens sharply.

“We are excited about what this approval means for patients living with prostate cancer, and that physicians now have an important and much-needed treatment option that has been shown to delay the progression of castration-resistant prostate cancer,” Mammen said in a statement.

Matthew Smith, director of the Genitourinary Malignancies Program at the Massachusetts General Hospital Cancer Center and the co-principal investigator of the Spartan trial, said with the approval of Erleada, doctors now “have the chance to offer hope for delaying metastases in patients with castration-resistant prostate cancer."

The news is certainly welcome to Janssen and parent company Johnson & Johnson, particularly after the January ruling of U.S. Patent & Trademark Office that nullified one of the pharma giant’s patents that covered the administration of prostate cancer drug Zytiga (abiraterone). The PTO ruling shaved 10 years off of the time that companies could field a generic of Zytiga.

Earlier this month, Pfizer unveiled late-stage data that showed prostate cancer drug Xtandi (enzalutamide) plus androgen deprivation therapy (ADT) significantly reduced the risk of developing metastases or death by 71 percent. Pfizer and development partner Astellas said the median time for the MFS in NM-CRPC patients was 36.6 months for men who received Xtandi in comparison to 14.7 months for those who only had the ADT treatment.