The Food and Drug Administration (FDA) has ordered a supplemental Biologics License Application (sBLA) for the approval of Elahere (mirvetuximab soravtansine-gynx) as use of treatments for patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer, all of which who have underwent one to three steps of treatment prior to the drug’s approval.
This approval was filed by ImmunoGen, Inc, the pharmaceutical company developing the drug.
“With the FDA’s filing of our sBLA, we are one step closer to securing full approval of ELAHERE in the US and establishing this novel (antibody drug conjugate) as the standard of care in FRα-positive platinum-resistant ovarian cancer,” said Dr. Michael Vasconcelles, ImmunoGen’s executive vice president, Research, Development and Medical Affairs.
“This regulatory milestone, achieved just over one year after Elahere’s accelerated approval, underscores the significance of the confirmatory MIRASOL data and the broader data set seen to date with Elahere, as well as the urgency with which our teams worked to bring this potentially practice-changing therapy to eligible patients in need. We look forward to collaborating closely with the FDA throughout the review process.”
Elahere is a receptor that is designed to target and kill attacking cancer cells. The drug is being used to treat patients with folate receptor-alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer, all of which have received prior treatment.
The phase 3 trial (MIRASOL) focuses on the use of Elahere as primary treatment in platinum-resistant ovarian cancer forms. Results from the study showed that Elahere revealed significant improvements in progression-free survival (PFS; from randomization or initiation of treatment to the occurrence of disease progression/death), objective response rate (ORR; the percentage of patients who achieve a response) and overall survival in comparison with chemotherapy as use of treatment.
The use of Elahere was granted approval in November 2022 based on past trial results (the SORAYA trial).
The application sent to the FDA prioritizing it’s approval has an action date of April 5, 2024, alongside it’s Prescription Drug User Fee Act.
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