FDA approves new indication for advanced prostate Ca treatment

Sep 26, 2019

The FDA has approved apalutamide (Erleada) for the treatment of patients with metastatic castration-sensitive prostate cancer, a new indication for the next-generation androgen receptor inhibitor.

The FDA has approved apalutamide (Erleada) for the treatment of patients with metastatic castration-sensitive prostate cancer, a new indication for the next-generation androgen receptor inhibitor.

Apalutamide was approved by the FDA in February 2018 for the treatment of non-metastatic castration-resistant prostate cancer.

Approval for the metastatic castration-sensitive prostate cancer indication was based on results from the phase III TITAN study, which were presented at the American Society of Clinical Oncology annual meeting in Chicago and published in The New England Journal of Medicine (2019; 381:13-24).

In the trial, apalutamide plus androgen deprivation therapy was found to significantly extend overall survival compared to placebo plus ADT, with a 33% reduction in the risk of death. Apalutamide plus ADT also significantly improved radiographic progression-free survival compared to placebo plus ADT, with a 52% lower risk of radiographic progression or death.

The most common adverse reactions (≥10%) that occurred more frequently in apalutamide-treated patients (≥2% over placebo) from the randomized placebo-controlled clinical trials of the treatment (TITAN and SPARTAN) were fatigue, arthralgia, rash, decreased appetite, fall, weight decrease, hypertension, hot flush, diarrhea, and fracture.

"Prostate cancer is more difficult to treat once it spreads, and for patients with castration-sensitive disease, it is clear that androgen deprivation therapy alone is often not enough. Results from the TITAN study showed that, regardless of the extent of disease, patients with metastatic castration-sensitive prostate cancer have the potential to benefit from treatment with apalutamide in addition to ADT,” Kim Chi, MD, of BC Cancer, Vancouver and TITAN principal investigator, said in a statement.

For prescribing information on apalutamide, click here.