FDA approves apalutamide for non | 合法藥品大搜索

2018年5月3日—FDAapprovesapalutamidefornon-metastaticcastration-resistantprostatecancer...ListentotheFDAD.I.S.C.O.podcastaboutthisapproval.On ...

Listen to the FDA D.I.S.C.O. podcast about this approval[1].

On February 14, 2018, the Food and Drug Administration approved apalutamide (Erleada™, Janssen Biotech, Inc.) for patients with non-metastatic castration-resistant prostate cancer (NM-CRPC).

Approval was based on a multicenter, double-blind, clinical trial (SPARTAN, NCT01946204) randomizing 1,207 patients with NM-CRPC (2:1) to receive either apalutamide, 240 mg orally once daily in combination with ADT (medical castration or surgical castration) (n=806), or placebo once daily with ADT (n=401).

The major efficacy endpoint was metastasis-free survival (MFS). MFS was defined as the time from randomization to the time of first evidence of distant metastasis (new bone or soft tissue lesions or enlarged lymph nodes outside the pelvis), or death d...