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Bayer (OTCPK:BAYZF) on Wednesday announced plans to seek an expanded label for its prostate cancer therapy Nubeqa (darolutamide) after the oral androgen receptor inhibitor (ARi) as part of combination therapy reached the main goal in a new Phase 3 trial.
The German drugmaker said darolutamide with androgen deprivation therapy (ADT) reached the primary endpoint of radiological progression-free survival versus placebo + ADT in a Phase 3 trial called ARANOTE in metastatic hormone-sensitive prostate cancer (mHSPC).
The safety results between darolutamide + ADT and placebo + ADT were found to be consistent and similar to the drug's tolerability profile established in ARASENS and ARAMIS Phase 3 trials, the company said.
Darolutamide, jointly developed by Bayer (OTCPK:BAYZF) and Finnish pharma company Orion (OTCPK:ORINY), is already approved for mHSPC 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 extend Nubeqa's clinical indications.
"Following potential regulatory approval, physicians can tailor treatment plans with or without docetaxel based on individual patient's needs," said Christian Rommel, head of R&D at Bayer's (OTCPK:BAYZF) pharma division.
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