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FDA expands Erleada approval for prostate cancer


Kim M. Chi

Kim N. Chi

The FDA expanded the approval of apalutamide to include treatment of men with metastatic castration-sensitive prostate cancer.

Apalutamide (Erleada, Janssen) — an oral androgen receptor inhibitor — already had been approved for the treatment of nonmetastatic castration-resistant prostate cancer.

The FDA based the new indication on results of the randomized phase 3 TITAN study, which included 1,052 patients with metastatic castration-sensitive prostate cancer from 23 countries in North America, Latin America, South America, Europe and the Asia-Pacific region.

The study included men with low- or high-volume disease. Some had newly diagnosed disease and others had received prior definitive local therapy or prior treatment with up to six cycles of docetaxel for metastatic disease.

Researchers assigned men to androgen deprivation therapy plus either apalutamide 240 mg daily (n = 524) or placebo (n = 527).

OS and radiographic PFS served as dual primary endpoints. Secondary endpoints included time to cytotoxic chemotherapy, time to pain progression, time to chronic opioid use and time to skeletal-related events.

As HemOnc Today previously reported, the results — presented at this year’s ASCO Annual Meeting and published simultaneously in The New England Journal of Medicine — showed the addition of apalutamide to ADT significantly extended OS (HR = 0.67; 95% CI, 0.51-0.89) and radiographic PFS (HR = 0.48; 95% CI, 0.39-0.6).

After median follow-up of 22.7 months, 2-year OS rates were 84% for ADT plus apalutamide and 78% for ADT plus placebo.

The most common adverse events observed among apalutamide-treated patients included fatigue, arthralgia, rash, decreased appetite, falls, weight loss, hypertension, hot flushes, diarrhea and fractures.

“Prostate cancer is more difficult to treat once it spreads, and for patients with castration-sensitive disease, it is clear that ADT alone is often not enough,” Kim N. Chi, MD, senior scientist at BC Cancer Agency and principal investigator of the TITAN study, said in a Janssen-issued press release. “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.”

The FDA previously granted priority review designation to apalutamide for this indication.

“Erleada has the potential to change how patients with prostate cancer are treated, regardless of the extent of the disease or prior docetaxel treatment history, by delaying disease progression and prolonging survival,” Margaret Yu, MD, vice president and prostate cancer disease area leader with Janssen Research & Development LLC, said in the release.

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