J&J’s prostate cancer drug recommended by NICE
pharmafile | September 8, 2021 | News story | Research and Development |
J&J have announced NICE are recommending apalutamide for treating prostate cancer following new draft guidance by the body.
This is based on the results of Phase III Titan and Spartan studies, which reveal that apalutamide (ERLEADA) increases the lifespan of prostate cancer patients, and halts the progression of the disease. Those eligible can access apalutamide through the NHS in England and Wales.
With over 42,500 people diagnosed with prostate cancer every year in England and Wales, approximately 13% have metastatic disease at diagnosis, meaning that the cancer has spread to other parts of the body. Metastatic hormone-sensitive prostate cancer (mHSPC) denotes prostate cancer that still responds to androgen deprivation therapy (ADT), and patients have an overall median survival rate of 45 months. This signals that new treatment options are imminent.
The Phase III trial, Titan, included 1,052 male patients in a placebo-controlled, double blind study, and concluded that Apalutamide is clinically effective when combined with ADT as compared to placebo plus ADT. The adverse effects of apalutamide plus ADT were also shown to be tolerable.
Apalutamide is an oral androgen receptor, which works by blocking the androgen signaling pathway in prostate cancer cells, inhibiting the growth of cancer cells. It is recommended for those who are at high risk of developing metastatic prostate cancer, and in adult men with mHSPC in combination with ADT.
“Today’s positive recommendation for apalutamide marks a significant milestone in our mission to bring new therapeutic options to patients with mHSPC and non-metastatic hormone-relapsed prostate cancer,” says Sarah Scanlon, Business Unit Director of Oncology, Haematology, and Pulmonary Hypertension.
Lina Adams
