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Myovant Ready To File Relugolix For Prostate Cancer

 
• By Joseph Haas

Secondary endpoint assessing cardiovascular risk may offer important differentiation from AbbVie’s Lupron. Myovant accelerated the prostate cancer filing soon after slowing the planned relugolix submission for uterine fibroids.

Cancer cell division of two prostate cancer cells in the final stage of cell division (cytokinesis) cytoplasm divides. the cells are joined by several thin cytoplasmic bridges. They to form tumours
Myovant now is on pace for two FDA filings of relugolix in 2020

Myovant Sciences Ltd. said it has met the regulatory standards it will need to file its daily, oral GnRH receptor antagonist relugolix for approval in advanced prostate cancer both within and outside the US, so the Swiss firm now has US Food and Drug Administration filings for both prostate cancer and uterine fibroids on tap in 2020.

CEO Lynn Seely told an investor call on 19 November that, in the second quarter, Myovant will file a new drug application for FDA approval of relugolix in advanced prostate cancer, ahead of an expected third-quarter readout of subpopulation data in metastatic patients from the same prostate cancer trial

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