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.”
- 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. https://bit.ly/2A5LHSI. Accessed November 19, 2018.
- 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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