Janssen Seeks Expanded FDA Approval of Erleada to Treat Metastatic Castration-sensitive Prostate Cancer

Janssen has submitted an application with the U.S. Food and Drug Administration (FDA) seeking the approval of its androgen receptor inhibitor Erleada (apalutamide) for patients with metastatic castration-sensitive prostate cancer (CSPC).

The supplemental new drug application is based on data from the ongoing Phase 3 TITAN clinical trial (NCT02489318), which showed that adding Erleada to first-line androgen deprivation therapy (ADT) extended survival and delayed disease progression or death in these patients.

It is being reviewed under the FDA’s Real-Time Oncology Review program, a pilot program that allows the FDA to start reviewing clinical data before an official application is submitted. The new program is intended to accelerate the review process so that treatments are available for patients as soon as possible.

“This submission marks an important step in providing a potential treatment option for patients with metastatic castration-sensitive prostate cancer, regardless of prior treatment or the extent of their disease,” Craig Tendler, MD, vice president of oncology clinical development and medical affairs in Janssen’s research and development division, said in a press release.

“We look forward to closely collaborating with the FDA through the efficient Real-Time Oncology Review pilot program with the goal of bringing Erleada to an earlier population of patients with metastatic prostate cancer as soon as possible,” he added.

Erleada is an oral agent that prevents the binding of testosterone to the androgen receptor, blocking signals that prostate cancer cells require to grow and proliferate. It is already approved in the U.S. and Europe for preventing metastasis in men with castration-resistant prostate cancer.

TITAN was designed to investigate if adding Erleada to standard ADT could improve the outcomes of prostate cancer patients whose cancer had spread to distant organs but responded to prior ADT treatment before the cancer spread.

It enrolled 1,052 patients and randomly assigned them to once-daily, oral Erleada plus ADT, or a placebo plus ADT. Treatment was continued until patients experienced disease progression or unacceptable toxicity.

The study’s primary goals were overall survival and the time to disease progression or death, and secondary measures included time to chemotherapy, time to worsening of pain, time to opioid use, and time to skeletal-related event — including fractures, bone metastasis, or spinal cord compression.

While TITAN’s main goals have been achieved, the final results have not yet been disclosed. The company will present the findings during the American Society of Clinical Oncology annual meeting May 31 in Chicago.

The study is titled, “First results from TITAN: A phase III double-blind, randomized study of apalutamide (APA) versus placebo (PBO) in patients (pts) with metastatic castration-sensitive prostate cancer (mCSPC) receiving androgen deprivation therapy (ADT).”