FDA’s approval of darolutamide (Nubeqa) to treat prostate cancer is expected to produce a major windfall for joint drug developers Bayer and Orion Corp.
Approved under FDA’s Priority Review designation, Nubeqa is a non-steroidal androgen receptor inhibitor (ARi) that treats patients with non-metastatic castration-resistant prostate cancer (nmCRPC). “The androgen receptor inhibitor has a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells,” Bayer said in a statement.
Earlier this year, Finland-based Orion said it was eligible to receive a milestone payment of 45 million euros ($50 million) upon first commercial sales of the drug in the US, KDAL reported.
“Patients at this stage of prostate cancer typically don’t have symptoms of the disease. The overarching goals of treatment in this setting are to delay the spread of prostate cancer and limit the burdensome side effects of therapy,” said Matthew Smith, MD, PhD, director of the Genitourinary Malignancies Program, Massachusetts General Hospital Cancer Center, in the Bayer statement. “This approval marks an important new option for the prostate cancer community.”
More than 73,000 men in the US are estimated to have a CRPC diagnosis in 2019. About one-third of men with non-metastatic CRPC go on to develop metastases within 2 years.
“With the approval of darolutamide, we now have a new therapy that extends MFS and allows physicians greater flexibility to treat men living with nmCRPC,” said Robert LaCaze, member of the executive committee of Bayer's Pharmaceuticals Division and head of the Oncology Strategic Business Unit, in the statement.
FDA’s approval of the drug is based on a Phase 3 trial evaluating darolutamide plus ADT, “which demonstrated a highly significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS),” Bayer said. There was a median of 40.4 months versus 18.4 months for placebo plus ADT.
The MFS result was additionally supported by a delay in time to pain progression as compared to placebo plus ADT. All other secondary endpoints, time to cytotoxic chemotherapy, and time to a symptomatic skeletal event, demonstrated a benefit in favor of darolutamide.
Bayer has filed for approval of the compound in the European Union (EU), Japan, and with other health authorities.