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FDA to Review Confirmatory Data for Elahere in Platinum-Resistant Ovarian Cancer

The FDA has accepted for Priority Review the sBLA supporting the conversion to full approval of Elahere for platinum-resistant ovarian cancer. ....

Michael Vasconcelles , Drug Administration , Priority Review , Biologics License Application , Executive Vice President , Prescription Drug User Fee Act ,

FDA Grants Priority Review to Mirvetuximab Soravtansine in FRα+ Platinum-Resistant Ovarian Cancer

The FDA has granted priority review to the supplemental biologics license application seeking the conversion of the accelerated approval of mirvetuximab soravtansine-gynx in patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who previously received 1 to 3 lines of systemic treatment to full approval. ....

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FDA to Review Confirmatory Data for Elahere in Platinum-Resistant Ovarian Cancer

The FDA has accepted for Priority Review the sBLA supporting the conversion to full approval of Elahere for platinum-resistant ovarian cancer. ....

Michael Vasconcelles , Drug Administration , Priority Review , Biologics License Application , Executive Vice President , Prescription Drug User Fee Act ,

FDA Grants Priority Review of ImmunoGen's Supplemental Biologics License Application for ELAHERE in Platinum-Resistant Ovarian Cancer

WALTHAM - ImmunoGen, Inc. , a leader in the expanding field of antibody-drug conjugates for the treatment of cancer, today announced that the US Food and Drug Administration has filed the. ....

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FDA Grants Priority Review of ImmunoGen's Supplemental Biologics License Application for ELAHERE® (mirvetuximab soravtansine-gynx) in Platinum-Resistant Ovarian Cancer

FDA Grants Priority Review of ImmunoGen's Supplemental Biologics License Application for ELAHERE® (mirvetuximab soravtansine-gynx) in Platinum-Resistant Ovarian Cancer
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