Health Canada extends approval of Bayer’s darolutamide
Health Canada has granted marketing authorisation for Bayer’s oral androgen receptor inhibitor (ARi) Nubeqa (darolutamide) for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).
This authorisation is based on results from the Phase III ARANOTE trial, which showed that darolutamide plus ADT reduced the risk of radiological progression or death by 46% compared to placebo plus ADT in patients with mCSPC.
With this additional marketing authorisation, darolutamide plus ADT is the first ARi indicated in Canada for the treatment of adult patients with mCSPC, either with or without docetaxel.
In addition, darolutamide is approved for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease.
“Clinical data from the ARANOTE trial showed that darolutamide is both efficacious and well tolerated as a combination therapy with androgen-deprivation therapy,” said Fred Saad, Professor and Chairman of Surgery and Director of Genitourinary Oncology at the University of Montreal Hospital Center (CHUM), and Principal Investigator of the ARANOTE trial. “Today’s approval further expands options for how physicians can use Nubeqa in the treatment of mCSPC, giving them greater flexibility in choosing treatment plans for their patients.”
In the ARANOTE trial, 669 patients were randomized 2:1 to receive 600mg of darolutamide twice daily or matching placebo in addition to ADT.
Darolutamide was developed jointly by Bayer and Orion Corporation, a Finnish pharmaceutical company.
“This latest authorisation reaffirms Nubeqa’s role as a therapy for men with prostate cancer,” said Shurjeel Choudhri, Senior Vice President and Head of Medical and Scientific Affairs for Bayer Canada. “We extend our thanks to the scientists, doctors, patients, and their families for their contributions that allowed us to offer this new treatment option for metastatic castration-sensitive prostate cancer.”
Diana Turner, Senior Digital Content Editor, DDW