Apalutamide is approved by the FDA for the treatment of patients with non-metastatic castration-resistant prostate cancer or metastatic castration-sensitive prostate cancer.
A once-daily tablet of apalutamide (Erleada) is now available for patients with prostate cancer receiving the androgen receptor inhibitor, accordingto Janssen Pharmaceutical Companies of Johnson & Johnson.1
Apalutamide is approved by the FDA for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) or metastatic castration-sensitive prostate cancer (mCSPC). These patients now have the option of receiving their treatment as one 240-mg tablet or the previously available regimen of four 60-mg tablets.
“Each person and their cancer are unique and, as such, there is no one-size-fits-all approach to treatment,” Luca Dezzani, MD, vice president, Medical Affairs, Solid Tumor, Janssen Scientific Affairs, LLC, stated in a press release. "The availability of 240-mg and 60-mg strength options of Erleada demonstrates Janssen’s commitment to prostate cancer patients and provides prescribers flexibility in dosing and methods of administration to fit each patient’s unique needs.”
Apalutamide was initially approved by the FDA in 2018 for the treatment of patients with nmCRPC. The approval was based on the phase 3 SPARTAN trial. The data from the trial that the FDA reviewed at the time showed that apalutamide reduced the risk of metastasis or death by 72% in patients with nmCRPC.2 The median metastasis-free survival was 40.5 months in the apalutamide arm versus 16.2 months in the placebo arm (HR, 0.28; P <.0001).
The FDA expanded this approval in 2019 to include patients with mCSPC. This approval was based on findings from the phase 3 TITAN trial. The study data reviewed by the FDA showed that apalutamide plus androgen deprivation therapy (ADT) led to a 33% reduction in the risk of death compared with placebo and ADT in this patient population (HR, 0.67; P = .0053).3
Apalutamide is currently being explored in several combinations and settings. For example, findings from the phase 3 PRESTO trial presented at the 2022 ESMO Congress showed that intensification of ADT with the addition of apalutamide has potential as a treatment for patients with high-risk biochemically relapsed prostate cancer.4 At a median follow-up of 21.5 months, the median PSA progression-free survival was 24.9 months with apalutamide plus ADT versus 20.3 months with ADT alone (HR, 0.52; P = .00047).
1. ERLEADA® (apalutamide), First-and-Only Next-Generation Androgen Receptor Inhibitor with Once-Daily, Single-Tablet Option, Now Available in the U.S. Published online and accessed April 3, 2023. https://bit.ly/40XgcF7
2. Small EJ, Saad F, Chowdhury S et al. SPARTAN, a phase 3 double-blind, randomized study of apalutamide (APA) versus placebo (PBO) in patients (pts) with nonmetastatic castration-resistant prostate cancer (nmCRPC). J Clin Oncol 36, 2018 (suppl 6s; abstract 161).
3. Chi KN, Agarwal N, Bjartell A, et al. Apalutamide for metastatic, castration-sensitive prostate cancer [published online May 31, 2019]. N Engl J Med. doi: 10.1056/NEJMoa1903307.
4. Aggarwal R, Heller G, Hillman D, et al. PRESTO: A phase III, open-label study of androgen annihilation in patients (pts) with high-risk biochemically relapsed prostate cancer (AFT-19).Ann Oncol. 2022;33(suppl 7):S808-S869. doi: 10.1016/annonc/annonc1089