Date: 2017-12-21

Type of information: Submission of a Market Application in the US

Product name: apalutamide

Compound: apalutamide

Therapeutic area: Cancer - Oncology

Action mechanism:

  • antiandrogen/androgen receptor blocker. Apalutamide is an investigational, next-generation oral androgen receptor inhibitor that inhibits the action of androgen in prostate cancer cells, and prevents binding of androgen to the androgen receptor, and translocation of the androgen receptor to the nucleus of the cancer cell. The compound is acting as a selective competitive antagonist of the androgen receptor.

Company: Janssen Biotech, a J&J company (USA - NJ)

Disease: non-metastatic castration-resistant prostate cancer (CRPC)

Latest news:

  • • On December 21, 2017, Janssen Biotech announced that the FDA has granted Priority Review designation for the New Drug Application (NDA) for apalutamide, an investigational, next-generation oral androgen receptor (AR) inhibitor for the treatment of men with non-metastatic castration-resistant prostate cancer (CRPC). Currently, there are no FDA -approved treatments for patients with non-metastatic CRPC. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target date of April 2018 to render a decision on the apalutamide application.
  • The NDA submission for apalutamide was completed on October 10, 2017. It is based on Phase 3 data from the pivotal ARN-509-003 (SPARTAN) clinical trial, which assessed the safety and efficacy of apalutamide versus placebo in men with non-metastatic CRPC who have a rapidly rising prostate specific antigen (PSA) despite receiving continuous androgen deprivation therapy.These men with a rapidly rising PSA are at high risk for developing metastatic disease.The primary endpoint of this study was metastasis-free survival (MFS). MFS is the time from randomization to first evidence of confirmed metastasis, or time to death. The SPARTAN study results have been accepted for oral presentation at the ASCO Genitourinary Cancers Symposium on Thursday, February 8, 2018 , in San Francisco .


Submission of marketing authorization application USA : 2017-10-10

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization:

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Favourable opinion USA:

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Pediatric exclusivit _USA:

Pediatric exclusivity UE:

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Other news:

Is general: Yes