Bayer files prostate cancer drug darolutamide with EU regulators

After filings in the US and Japan, Bayer has submitted data to European regulators for its prostate cancer drug darolutamide.

This is the third filing in two weeks for darolutamide, meaning that the drug is now under review with regulators from three of the largest drug markets in the world.

Bayer has filed results of the phase 3 ARAMIS study, testing darolutamide in patients with non-metastatic castration-resistant prostate cancer, with regulators from the European Medicines Agency (EMA).

The regulator usually takes over a year to review drugs, paving the way for a European launch some time in mid-2020 if things go well.

Bayer is also in discussions with other health authorities regarding submissions.

With darolutamide, developed in partnership with Finland’s Orion Corporation, 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 their rivals and is tipped to break through the billion-euro annual sales barrier if approved.

However, while analysts think that the side effect profile is favourable based on trial data so far, efficacy is comparable and this may not be enough to win over prescribers looking for an improvement on established therapies.

ARAMIS showed that in men with non-metastatic disease, darolutamide produced a statistically significant improvement in metastasis-free survival for darolutamide plus androgen deprivation therapy (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.

Scott Fields, senior vice president and head of Oncology Development of Bayer AG's Pharmaceutical Division, said: “Men are typically asymptomatic at this stage of prostate cancer. Therefore, it is critical that they have treatment options, which not only delay the development of metastases, but also limit burdensome side effects of therapy, so that these men can continue with their day-to-day lives.”