Janssen‘s hormone therapy Erleada (apalutamide) may soon be used in Europe for men with castration-resistant prostate cancer (CRPC) who have a high risk of their disease spreading, after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended its approval.
The European Commission will now review CHMP’s recommendation before making a final decision.
“We are pleased with the CHMP’s decision to recommend approval of apalutamide for the treatment of patients with high-risk, non-metastatic, castration-resistant prostate cancer,” Ivo Winiger-Candolfi, MD, lead of Janssen Oncology solid tumor therapy area in Europe, Middle East, and Africa, Cilag GmbH International, said in a press release.
“We know that each prostate cancer patient journey is unique and today’s positive CHMP opinion brings us one step closer to offering patients an effective treatment option that delays the spread of their disease,” he said.
Metastasis is a major cause of complications and death among men with prostate cancer. Nearly all men who die from the condition first see their disease spread to distant parts of the body. Thus, researchers have been focusing on the prevention of metastasis in men at risk, which may significantly extend their lives and improve their quality of life.
Erleada is an oral agent that prevents the binding of testosterone to the androgen receptor, blocking signals that prostate cancer cells require to grow and proliferate.
In the SPARTAN Phase 3 trial (NCT01946204) — which led to the CHMP’s positive opinion and to Erleada’s approval in the United States — the treatment was compared to a placebo in 1,207 non-metastatic CRPC men whose PSA levels were rapidly rising while receiving androgen deprivation therapy.
During the trial, all participants kept receiving hormone therapy, and were randomly assigned oral Erleada, or a placebo, once daily.
Erleada treatment extended the time patients lived without disease spread by over two years — 40.5 months versus 16.2 months — representing a 72% reduction in the risk of disease progression or death.
The treatment also extended the time patients lived without disease worsening, and the time to symptomatic progression. And while patients on the placebo showed a trend toward a deterioration of quality of life, quality of life scores were preserved among patients receiving Erleada.
Erleada was overall well-tolerated, with patients experiencing similar rates of adverse events as those on the placebo. The most common serious or life-threatening side effects were high blood pressure, rash, falls, and fractures.
“Nearly 90 percent 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,” said Simon Chowdhury, MD, consultant medical oncologist, Guy’s and St Thomas’ Hospitals. “Data from the SPARTAN study showed that apalutamide significantly improves metastasis-free survival for patients with castration-resistant prostate cancer.”