Erleada apalutamide’s landmark approval established a new primary endpoint in prostate cancer that shortens the time it takes to run the trials by up to five years, and paves the way for treating disease before it’s fully advanced.
On Feb. 14, FDA approved the second-generation androgen receptor antagonist from Johnson & Johnson to treat non-metastatic castration-resistant prostate cancer (CRPC) based on the Phase III SPARTAN trial, which used metastasis free survival (MFS) rather than the benchmark overall survival (OS) as the primary endpoint.
The approval also paves the way for would-be competitors whose compounds have reached regulators or are completing Phase III studies using the same endpoint.
MFS is defined as the time between trial randomization and the first evidence of distant metastases confirmed by imaging or histology, or death from any cause.
“I think adding a drug that’s this potent and effective may increase the number of patients that are cured.”
That means it can provide a much earlier readout of efficacy than OS, which can take over 10 years to assess in non-metastatic prostate cancer patients.
Mark Wildgust, VP of oncology global medical affairs, believes J&J’s decision to use MFS cut three to five years off the approval timeline.
J&J chose to study Erleada in non-metastatic patients because the company reasoned that