FDA approves apalutamide for treatment of mCSPC here in US


Yesterday (September 17, 2019), the US Food and Drug Administration approved apalutamide (Erleada) for treatment of men with metastatic castration-sensitive prostate cancer (mCSPC) — i.e., men who have responded successfully to androgen deprivation therapy (ADT) using either bilateral orchiectomy or treatment with a gonadotropin-releasing hormone analog (also known as an LHRH agonist, such a Lupron). Apalutamide had previously been approved only for the treatment of non-metastatic, castration-resistant prostate cancer (nmCRPC)

This new approval is based on data from the TITAN trial (NCT02489318), as previously reported here and published in the New England Journal of Medicine in July this year (see here).

The approval of apalutamide in this new indication is again in combination with some form of ADT and not as a single agent.

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