Darolutamide FDA approval : German pharma giant Bayer and Finnish pharma company Orion have secured approval from the US Food and Drug Administration (FDA) for their non-steroidal androgen receptor inhibitor (ARi) Nubeqa (darolutamide) for the treatment of men having non-metastatic castration-resistant prostate cancer (nmCRPC).

The FDA approval of darolutamide was driven on the findings of the phase 3 clinical trial called ARAMIS in 1,509 patients. The ARAMIS clinical trial assessed the safety and efficacy of the compound in nmCRPC patients who are currently under androgen deprivation therapy (ADT) and are at highly vulnerable for developing metastatic disease.

The late-stage clinical trial showed a highly significant improvement in metastasis-free survival (MFS), defined as the primary efficacy endpoint, with a median of 40.4 months compared to 18.4 months for placebo plus ADT.

Bayer and Orion bag Darolutamide FDA approval for non-metastatic castration-resistant prostate cancer. Photo courtesy of Bayer AG.

Darolutamide, which is jointly developed by Bayer and Orion, was approved under the FDA Priority Review designation, which is reserved for drugs that may offer significant improvements in the safety or effectiveness of the treatment for serious disorders.

Timo Lappalainen – President and CEO of Orion, commenting on Darolutamide FDA approval, said: “The approval of Nubeqa in the US is a significant event for prostate cancer patients, their caregivers, healthcare professionals as well as for Orion and Bayer. The fact that Orion’s latest oncology invention, Nubeqa was approved under the FDA Priority Review process, speaks for the value of treatment option.”

According to Bayer and Orion, the androgen receptor inhibitor binds to the receptor with high affinity and shows strong antagonistic activity, as a result blocking the receptor function and the prostate cancer cells from growing.

Commenting on Darolutamide FDA approval, Robert LaCaze – Member of the Executive Committee of Bayer’s Pharmaceuticals Division and Head of the Oncology Strategic Business Unit, said: “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.

“Bayer is proud to take this latest step forward in the nmCRPC treatment landscape. Darolutamide is the newest addition to our prostate cancer portfolio and reflects Bayer’s commitment to finding treatments for men at different stages along the prostate cancer continuum.”

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