FDA accepts filing of NDA for Lynparza for patients with metastatic castration-resistant prostate cancer . AstraZeneca + Merck Inc.
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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).