On November 16, 2018 The Janssen Pharmaceutical Companies of Johnson & Johnson reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) reported it has issued a positive opinion for apalutamide, a next generation oral androgen receptor inhibitor for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease.2 The CHMP’s positive opinion will now be reviewed by the European Commission (EC), which has the authority to grant approval for the use of apalutamide (Press release, Johnson & Johnson, NOV 16, 2018, View Source [SID1234531398]).
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The CHMP’s positive opinion is based on data from the pivotal SPARTAN Phase 3 clinical study which assessed the safety and efficacy of apalutamide versus placebo in patients with nmCRPC who have a rapidly rising prostate specific antigen (PSA) level despite receiving continuous androgen deprivation therapy (ADT). The SPARTAN clinical study showed that apalutamide, when added to ADT, significantly reduced the risk of developing distant metastasis or death (metastasis free survival [MFS]) by 72 percent, compared to placebo in combination with ADT (HR = 0.28; 95% CI, 0.23-0.35; P < 0.001). The median MFS was improved by over two years (40.5 months vs 16.2 months) in patients with nmCRPC whose PSA is rapidly rising.1 This study was published in The New England Journal of Medicine.
The most common Grade 3/4 treatment-emergent adverse events in the SPARTAN study were hypertension (14.3 percent vs. 11.8 percent), rash (5.2 percent vs. 0.3 percent), fall (1.7 percent vs. 0.8 percent) and fracture (2.7 percent vs. 0.8 percent). Treatment discontinuation due to adverse events was 11 percent in the apalutamide arm compared to 7 percent in the placebo arm. Rates of serious adverse events were similar in the apalutamide in combination with ADT arm versus placebo in combination with ADT arm (25 percent vs. 23 percent respectively).1
"Data from the SPARTAN study showed that apalutamide significantly improves metastasis free survival for patients with castration-resistant prostate cancer," said Dr Simon Chowdhury, Consultant Medical Oncologist, Guy’s and St Thomas’ Hospitals. "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."*
"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," said Dr. Ivo Winiger-Candolfi M.D., Janssen Oncology Solid Tumor Therapy Area Lead, Europe, Middle East and Africa, Cilag GmbH International. "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."
ENDS
About Non-Metastatic Castration-Resistant Prostate Cancer
Non-metastatic castration-resistant prostate cancer (CRPC) refers to a disease stage when the cancer no longer responds to medical or surgical treatments that lower testosterone, but has not yet been discovered in other parts of the body using a bone scan or CT scan.3 Features include: lack of detectable metastatic disease; rapidly rising prostate-specific antigen while on androgen deprivation therapy (ADT) and serum testosterone level below 50 ng/dL.3 Ninety percent of patients with non-metastatic CRPC will eventually develop bone metastases, which can lead to pain, fractures and spinal cord compression.4 The relative 5-year survival rate for patients with distant stage castration sensitive or castration resistant prostate cancer is 30 percent.5,6
About apalutamide
Apalutamide is an investigational, next-generation oral androgen receptor (AR) inhibitor that blocks the androgen signaling pathway in prostate cancer cells. Apalutamide inhibits the growth of cancer cells in three ways: by preventing the binding of androgen to the AR; by stopping the AR from entering the cancer cells; and by preventing the AR from binding to the DNA of the cancer cell.7
Janssen submitted a Marketing Authorisation Application to the European Medicines Agency (EMA) in February 2018 seeking approval for apalutamide for the treatment of patients with high-risk non-metastatic castration-resistant prostate cancer (nmCRPC). Apalutamide received approval from the United States Food and Drug Administration for the treatment of patients with nmCRPC in February 2018, shortly followed by approvals in Canada, Australia, Argentina and Brazil.8,9,10,11