See the DrugPatentWatch profile for Miudella
Miudella, also known as mirvetuximab soravtansine, was approved by the U.S. Food and Drug Administration (FDA) on November 22, 2022 [1].
When might Miudella be available outside the U.S.?
The availability of Miudella in other countries depends on regulatory review and approval processes by each nation's health authorities. Information regarding its availability in specific markets can be found through local regulatory agencies or the drug's manufacturer.
What is mirvetuximab soravtansine used for?
Mirvetuximab soravtansine is approved for the treatment of adults with folate receptor-alpha positive, platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens [1].
How does Miudella work?
Mirvetuximab soravtansine is an antibody-drug conjugate. It targets cancer cells that express folate receptor-alpha. The antibody part of the molecule binds to the folate receptor-alpha on cancer cells, and then the drug is internalized, releasing a chemotherapy agent that kills the cancer cells [2].
What are the key clinical trial results for mirvetuximab soravtansine?
In the FORWARD I trial, mirvetuximab soravtansine demonstrated an objective response rate of 32% and a median progression-free survival of 4.3 months in patients with folate receptor-alpha positive, platinum-resistant ovarian cancer who had received one to three prior treatment regimens [3].
What are the risks associated with Miudella treatment?
Common side effects of mirvetuximab soravtansine include thrombocytopenia, neutropenia, nausea, vomiting, diarrhea, abdominal pain, fatigue, blurred vision, keratopathy, dry eye, and peripheral neuropathy [1]. Serious side effects can occur, and patients should discuss potential risks with their healthcare provider.
Where can I find more information on drug patents for mirvetuximab soravtansine?
Information on patents related to mirvetuximab soravtansine, including patent expiry dates and challenges, can often be found on specialized databases like DrugPatentWatch.com [4].
Who manufactures Miudella?
Miudella is manufactured by ImmunoGen, Inc. [5].
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**Sources
1. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-mirvetuximab-soravtansine-ovarian-cancer
2. https://www.cancer.gov/news-events/cancer-currents-blog/2022/mirvetuximab-soravtansine-mirvetuximab-approved-ovarian-cancer
3. https://www.nejm.org/doi/full/10.1056/NEJMoa2204840
4. https://drugpatentwatch.com/
5. https://www.immungen.com/