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23-09-2019 | Oncology | News | Article

approvalsWatch

Apalutamide approved by FDA for mCSPC

medwireNews: US men with metastatic castration-sensitive prostate cancer (mCSPC) may now be treated with apalutamide alongside androgen deprivation therapy, following approval by the US FDA.

The decision follows findings from the phase III TITAN study demonstrating a significant improvement in both overall and progression-free survival with the androgen receptor inhibitor versus placebo, when used in combination with a gonadotropin-releasing hormone analog or after bilateral orchiectomy.

Apalutamide was previously approved by the FDA for patients with nonmetastatic castration-resistant prostate cancer on the basis of the SPARTAN trial findings.

Apalutamide 240 mg should be given once daily with or without food; adverse events include fatigue, arthralgia, rash, gastrointestinal side effects, and fracture.

By Lynda Williams

medwireNews is an independent medical news service provided by Springer Healthcare. © 2019 Springer Healthcare part of the Springer Nature group

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