Janssen – a pharmaceutical arm of Johnson & Johnson – has announced that Erleada (apalutamide), in combination with androgen deprivation therapy (ADT), has been accepted by the Scottish Medicines Consortium (SMC) as an option for treating adults with metastatic hormone-sensitive prostate cancer (mHSPC) within NHS Scotland.
The SMC’s decision is based on positive results from the phase 2 TITAN study, which found the effects of Erleada plus ADT were ‘statistically significant’ compared with placebo plus ADT.
Erleada plus ADT was also found to ‘significantly improve’ both co-primary outcomes including radiographic progression-free and overall survival rates, and was generally well tolerated versus placebo plus ADT, Janssen reported.
Over 3,000 people are diagnosed with prostate cancer in Scotland every year, with over 30,000 currently living with the disease. People with mHSPC are estimated to make up 15-30% of all prostate cancer diagnoses and have been found to have a poor prognosis, with a median overall survival of approximately 52 months with standard ADT alone.
“Despite advancements in prostate cancer treatment, there remains a significant unmet need in finding additional treatment options where existing hormonal therapies may not be appropriate for all those living with prostate cancer once it has spread outside the prostate,” said Professor Rob Jones, consultant in medical oncology and professor of clinical cancer research at the University of Glasgow.
“The acceptance of [Erleada] for use in NHS Scotland adds another effective and generally well-tolerated treatment option for men in Scotland with one of the most common of male cancers,” Jones added.
Erleada inhibits the growth of cancer cells in three ways: by preventing the binding of androgen to the androgen receptor (AR), by inhibiting AR nuclear translocation and DNA binding, and by preventing AR-mediated gene transcription.
It is indicated for use in the UK for the treatment of patients with non-metastatic hormone-relapsed prostate cancer who are at high risk of developing metastatic disease, and in adult men with mHSPC in combination with ADT.
Amanda Cunnington, senior director of patient access and health affairs, Janssen-Cilag Limited, said: “This decision provides greater options to those living with mHSPC and brings us a step closer to ensuring patients across the UK can access effective treatments that have the potential to increase survival and improve quality of life.”