US FDA Approves Bayer’s Darolutamide to Treat Metastatic HSPC

The US health agency approved Darolutamide, developed by Bayer, to treat patients with metastatic hormone-sensitive prostate cancer (HSPC). Darolutamide can be given alongside docetaxel plus androgen deprivation therapy (ADT).

The efficacy of Darolutamide in the patients was demonstrated in the phase 2 trial. in particularly, use of Darolutamide despite placebo in combination with docetaxel plus ADT has significantly prolonged the primary endpoint of survival as well as improved different secondary endpoints like pain progression.

According to the US FDA, Darolutamide should be given at a dose of 600 mg two times daily with food, alongside 75 mg of docetaxel administered every three weeks for around six cycles. The Food and Drug Administration (FDA) of the United States highlights that the first dose of docetaxel should be administered within six weeks after the treatment of darolutamide begins.

Matthew Smith, director of the genitourinary malignancies program at Massachusetts General Hospital Cancer Center, said Darolutamide plus ADT highlights its proven tolerability, and provides a new option of treatment for patients.

Christine Roth, member of the executive committee of the pharmaceutical division and head of oncology SBU at Bayer, based on the data from the phase 3 trial, Darolutamide has demonstrated significant efficacy in mHSPC and nmCRPC.

This expansion of doralutamide indicates the commitment of Bayer to provide proven and tolerable options of treatment to eligible patients across different stages of prostate cancer.