EU approves Nubeqa for castration-resistant prostate cancer .- Orion + Bayer
The approval is based on Phase III ARAMIS trial results showing a statistically significant improvement in metastasis-free survival (MFS) for darolutamide plus androgen deprivation therapy (ADT) versus placebo plus ADT, and a favorable safety profile. Results demonstrated a highly significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS) of darolutamide plus ADT, with a median of 40.4 months, versus 18.4 months for placebo plus ADT (p<0.001), and a favorable safety profile. the compound is indicated for the treatment of men with non-metastatic castration-resistant prostate cancer (nmcrpc), who are at high risk of developing metastatic disease.></0.001),>
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Lantheus Holdings, Inc. presented results from a retrospective analysis of quantitative Pylarify (piflufolastat F18) PSMA (prostate specific membrane antigen) scan indices as a response imaging-biomarker to androgen deprivation therapy in veterans with newly diagnosed metastatic prostate cancer.
Myovant Sciences and Accord Healthcare, Ltd. announced that they have entered into an exclusive license agreement for Accord to commercialize relugolix for the treatment of advanced hormone-sensitive prostate cancer under the trade name Orgovyx (relugolix, 120 mg) in the European Economic Area, United Kingdom, Switzerland and Turkey, with the right of first negotiation if Myovant decides to enter into licensing arrangements in countries in the Middle East, Africa and India.
Bayer announced the FDA has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for the oral androgen receptor inhibitor (ARi) darolutamide in combination with docetaxel for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC).