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Bayer (OTCPK:BAYZF) announced on Wednesday that it plans to seek approval for its prostate cancer treatment Nubeqa (darolutamide) after the oral androgen receptor inhibitor (ARi) met the primary goal in a new Phase 3 trial as part of a combination treatment. Expand label.
The German drugmaker said darolutamide plus androgen deprivation therapy (ADT) achieved the highest efficacy compared with placebo + ADT in a Phase 3 trial called ARANOTE in metastatic hormone-sensitive prostate cancer (mHSPC). The primary endpoint was radiographic progression-free survival.
The company said the safety results between darolutamide + ADT and placebo + ADT were consistent and similar to the drug tolerability profile established in the ARASENS and ARAMIS Phase 3 trials.
Darolutamide, co-developed by Bayer (OTCPK:BAYZF) and Finnish pharmaceutical company Orion (OTCPK:ORINY), has been approved for the treatment of mHSPC in combination with ADT and chemotherapy.
Bayer (OTCPK:BAYRY) said full study results will be presented at a future medical event and the company will prepare global regulatory submissions to expand Nubeqa’s clinical indications.
“Following potential regulatory approval, physicians can tailor treatment plans with or without docetaxel based on their individual patient needs,” said Christian Rommel, head of research and development for Bayer’s (OTCPK:BAYZF) pharmaceuticals division. “
