Bayer gets Japanese approval for prostate cancer drug Nubeqa

Bayer and Orion’s prostate cancer drug Nubeqa (darolutamide) is gaining steam in its battle against rivals from J&J and Pfizer/Astellas as Japan becomes the latest country to approve the drug.

The Japanese Ministry of Health, Labor and Welfare (MHLW) has granted marketing authorisation to Nubeqa for the treatment of men with non-metastatic castration-resistant prostate cancer (nmCRPC). 

In Japan, over 89,000 men are estimated to be diagnosed with prostate cancer annually, making it the second most-common cancer diagnosis in Japanese men (after stomach cancer). 

The drug was approved by the FDA in July last year. With darolutamide, Bayer is hoping to take market share from J&J’s Erleada (apalutamide) and Pfizer/Astellas’ Xtandi (enzalutamide), which have become standard therapies at several different stages of the disease.

Bayer and Orion think that their drug may have a safety advantage over competitors and is tipped to break through the billion-euro annual sales barrier.

Analysts agree that the side effect profile is favourable based on trial data so far, but efficacy is comparable and this may not be enough to win over prescribers looking for an improvement on the rivals, which have only recently been approved in this use.

The Japanese approval, like the US greenlight, is based on data from the phase 3 ARAMIS trial in men with non-metastatic castration-resistant disease, which showed a statistically significant improvement in metastasis-free survival for darolutamide plus androgen deprivation therapy (ADT).

In ARAMIS, 1,509 patients were randomised in a 2:1 ratio to receive 600 mg of darolutamide twice a day or placebo along with ADT.

The trial showed that Nubeqa plus androgen deprivation therapy (ADT) demonstrated a highly significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS), with a median of 40.4 months versus 18.4 months for placebo plus ADT group.

J&J’s Erleada was first to market in this indication, approved in February last year after data in the SPARTAN trial showing MFS of 40.5 months, compared with 16.2 months in patients taking placebo.

Pfizer/Astellas’ rival Xtandi was approved in the same indication shortly after – in the PROSPER trial MFS was 36.6 months for those treated with Xtandi plus ADT, compared with 14.7 months in those treated with placebo and ADT.

Bayer is also developing darolutamide in metastatic hormone-sensitive prostate cancer, where the phase 3 prostate cancer trial ARASENS is testing its safety and efficacy.

Don't miss your daily pharmaphorum news.
SUBSCRIBE free here.