The US Food and Drug Administration (FDA) has granted approval for a supplemental New Drug Application (sNDA) of Orion and its partner Bayer’s Nubeqa (darolutamide) plus docetaxel to treat metastatic hormone-sensitive prostate cancer (mHSPC) patients.
The latest approval is based on positive data from the multicentre, double-blind, randomised, placebo-controlled Phase III ARASENS clinical trial that analysed the safety and efficacy of oral darolutamide plus androgen deprivation therapy (ADT) and the chemotherapy docetaxel in mHSPC patients.
It enrolled 1,306 subjects, who were categorised into a 1:1 ratio to receive 600mg darolutamide twice daily or placebo, along with ADT and docetaxel in both arms.
According to the findings, the combination treatment substantially lowered mortality risk by 32.5% in trial subjects versus those who received ADT plus docetaxel.
Overall survival was the trial’s primary endpoint.
Time to progression in pain, castration-resistant prostate cancer, first symptomatic skeletal event, the commencement of successive anticancer treatment, all analysed at 12‐week intervals, as well as adverse events (AEs) as a measure of safety and tolerability were the trial’s secondary endpoints.
The improvements in these secondary endpoints backed the benefit reported in the trial’s primary endpoint.
The application had previously received Priority Review designation from the regulatory agency and was filed under the Real-Time Oncology Review (RTOR) pilot programme of the FDA.
An oral androgen receptor inhibitor (ARi), darolutamide is being co-developed by Orion and Bayer.
In addition to the latest indication, darolutamide is approved for treating non-metastatic castration-resistant prostate cancer (nmCRPC) in men at increased risk of developing metastatic disease.
In May, Bayer informed intent to conclude an exclusive global licensing agreement with Atara Biotherapeutics for mesothelin-directed CAR T-cell therapies.