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EU Panel Backs Apalutamide in Nonmetastatic CRPC

Kristi Rosa
Published: Monday, Nov 19, 2018

Ivo Winiger-Candolfi, MD

Ivo Winiger-Candolfi, MD

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) granted support for approval of apalutamide (Erleada) for the treatment of adult patients with nonmetastatic castration-resistant prostate cancer (CRPC) who are at high risk of developing metastatic disease, according to Janssen Pharmaceutical Companies, the developer of apalutamide, which announced the decision in a news release.1

“Data from the SPARTAN study showed that apalutamide significantly improves MFS for patients with castration-resistant prostate cancer,” stated Simon Chowdhury, MA, MBBS, MRCP, PhD, a consultant medical oncologist at Guy’s and St. Thomas’ Hospitals, in the release. “Nearly 90% of patients with castration-resistant prostate cancer will eventually develop bone metastases. At that point, their prognosis worsens dramatically. Delaying the spread of cancer is, therefore, critical for patients living with prostate cancer.”


  1. Janssen Receives Positive CHMP Opinion For Erleada (Apalutamide) For Patients With Non-Metastatic Castration-Resistant Prostate Cancer Who Are At High Risk Of Developing Metastatic Disease [news release]. Janssen Pharmaceuticals. Published November 18, 2018. Accessed November 19, 2018.
  2. Smith M, Saad F, Chowdhury, S, et al. Apalutamide treatment and metastasis-free survival in prostate cancer. N Engl J Med. 2018;378(15):1408-1418. doi: 10.1056/NEJMoa1715546.

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