WALTHAM, Mass.--(BUSINESS WIRE)--ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that the US Food and Drug Administration (FDA) has filed the supplemental Biologics License Application (sBLA) supporting the conversion of the accelerated approval of ELAHERE® (mirvetuximab soravtansine-gynx) for the treatment of patients with folate receptor alpha (FR?)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens to full approval. The application has been granted Priority Review designation with a Prescription Drug User Fee Act (PDUFA) action date of April 5, 2024.
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ImmunoGen Announces European Medicines Agency Acceptance of Marketing Authorization Application for Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer
The efficacy of maintenance mirvetuximab soravtansine-gynx (Elahere) plus bevacizumab (Avastin) is being compared with bevacizumab alone in patients with folate receptor alpha (FR?)–positive recurrent platinum-sensitive epithelial ovarian, fallopian tube, or peritoneal cancers that did not progress on second-line triplet therapy in the phase 3 GLORIOSA study (NCT05445778).
WALTHAM, Mass.--(BUSINESS WIRE)--ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced detailed results from the Phase 3 confirmatory MIRASOL trial (GOG 3045/ENGOT OV-55) evaluating the safety and efficacy of ELAHERE® (mirvetuximab soravtansine-gynx) compared to chemotherapy in patients with folate receptor alpha (FR?)-positive platinum-resistant ovarian cancer (PROC). The results are being presented by Dr. Kathleen Moore in a late-breaking oral abstract session today at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois. These data have also been selected for the 2023 Best of ASCO program, which will be held this summer following the ASCO Annual Meeting.
ImmunoGen has reported positive top-line results from the Phase III confirmatory MIRASOL trial (GOG 3045/ENGOT OV-55) of ELAHERE (mirvetuximab soravtansine-gynx) for the treatment of folate receptor alpha (FR?)-positive platinum-resistant ovarian cancer.
WALTHAM, Mass.--(BUSINESS WIRE)--May 3, 2023-- ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced positive top-line data from the Phase 3 confirmatory MIRASOL trial (GOG 3045/ENGOT OV-55) evaluating the safety and efficacy of ELAHERE® (mirvetuximab soravtansine-gynx) compared to chemotherapy in patients with folate receptor alpha (FR?)-positive platinum-resistant ovarian cancer who have received one to three prior lines of therapy. Based on these data, the Company plans to submit a Marketing Authorization Application (MAA) in Europe and a supplemental Biologics License Application (sBLA) in the US for the conversion to a regular approval of ELAHERE.
New drug approvals were fewer in number in 2022. Is this a trend that will continue into 2023 or is the drop off just a cyclical anomaly?
The US Food and Drug Administration (FDA) has granted accelerated approval to mirvetuximab soravtansine (Elahere) for use in pretreated patients with folate receptor (FR) alpha–positive, platinum-resistant epithelial ovarian, fallopian tube, and primary peritoneal cancer. These patients can have received one to three prior lines of treatment.