The UK’s National Institute of Health and Care Excellence (NICE) has recommended Janssen’s Erleada (apalutamide)for the treatment of prostate cancer, after previously rejecting the therapy.
In May 2021, NICE published draft guidance rejecting Erleada combined with androgen deprivation therapy (ADT) for treating hormone-relapsed prostate cancer who are at high risk of the cancer spreading (nmHRPC), or hormone-sensitive prostate cancer that has already metastasised (mHSPC).
Current treatment for hormone-relapsed non-metastatic prostate cancer is ADT, alone or with darolutamide (another androgen receptor inhibitor).
Meanwhile, current treatment for hormone-sensitive metastatic prostate cancer is docetaxel (a chemotherapy drug) plus ADT or ADT alone for people who cannot take docetaxel.
NICE concluded in this draft guidance that, although trial results suggest that Erleada plus ADT improves progression-free survival and survival compared with placebo plus ADT, the evidence is uncertain.
At that time, NICE attributed this uncertainty to the fact that in the trial, some individuals could switch to other treatments and some could receive treatments not available in the NHS.
This also affected cost-effectiveness estimates, which fell above what NICE would consider an acceptable use of NHS resources.
However, after reconsidering the evidence, NICE has recommended Erleada for two indications within its marketing authorisation, including for treating mHSPC in adults if docetaxel is not suitable or cannot be tolerated, or for nmHRPC patients that are high risk of their cancer metastasising.
NICE said in a statement that patients who are unsuitable for and cannot tolerate docetaxel will be identified via a clinical framework based on individual risk.
“Today’s positive recommendation for apalutamide marks a significant milestone in our mission to bring new therapeutic options to patients with mHSPC and nmHRPC,” said Sarah Scanlon, business unit director, oncology, haematology and pulmonary hypertension.
“We are delighted that NICE has given the green light for apalutamide for both indications and look forward to seeing these groups of patients benefit from a new treatment option,” she added.