Prostate Cancer Treatment Seeks New Indication Authorization

Janssen Erleada requests FDA approval for the treatment of patients with metastatic castration-sensitive prostate cancer
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(Vax Before Cancer)

A supplemental New Drug Application (sNDA) has been submitted to the U.S. Food and Drug Administration (FDA) seeking approval of a new indication for ERLEADA® (apalutamide) for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC). 

The Janssen Pharmaceutical Compan’s sNDA is based on findings from the Phase 3 TITAN study, whose dual primary endpoints, overall survival (OS), and radiographic progression-free survival (rPFS), were both achieved. 

The sNDA is being reviewed by the FDA through the Real-Time Oncology Review (RTOR) program, which for certain applications allows the FDA to review data before the applicant formally submits the complete application. The program aims to explore a more efficient review process to help ensure treatments are available for patients as soon as possible. 

However, selection into the RTOR program does not guarantee or influence the approvability of the application.

These data will be presented at the upcoming American Society of Clinical Oncology Annual Meeting during an oral abstract session on Friday, May 31, 2020.

“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,” said Craig Tendler, M.D., Vice President, Oncology Clinical Development and Medical Affairs, Janssen Research & Development, LLC, in a press statement. 

“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.”

TITAN (NCT02489318) is a Phase 3 randomized, placebo-controlled, double-blind study in patients with mCSPC regardless of the extent of disease, and prior treatment with docetaxel or treatment of localized disease. More than 1,050 patients with mCSPC were randomized to receive either ERLEADA plus androgen deprivation therapy (ADT), or placebo plus ADT. 

The TITAN study included mCSPC patients with both low and high-volume disease, those who were newly diagnosed or those who have received prior definitive local therapy, or prior treatment with up to six cycles of docetaxel. Participants were treated until disease progression or the occurrence of unacceptable treatment-related toxicity, or the end of treatment. The dual primary endpoints of the study are OS and rPFS. 

Secondary endpoints include time to chemotherapy, time to pain progression, time to chronic opioid use, and time to a skeletal-related event.

ERLEADA® became the first treatment to receive FDA approval for this disease state on February 14, 2018.

Metastatic prostate cancer is cancer that has spread to another part of the body. Metastatic castration-sensitive prostate cancer refers to prostate cancer that still responds to ADT. Patients with mCSPC tend to have a poor prognosis, with a median OS of fewer than 5-years, underscoring the need for new treatment options

Learn more at Janssen.

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