Elahere (mirvetuximab soravtansine)
Elahere is a new prescription medicine used to treat adults with folate receptor-alpha (FRα) positive cancer of the ovary, fallopian tubes, or peritoneum who have stopped responding to platinum‑based chemotherapy and who have had one to 3 chemotherapy treatments before. Elahere contains the active ingredient mirvetuximab soravtansine.
Elahere is an infusion (drip) given into the vein (intravenously) to treat adults with cancer of the ovary, fallopian tubes (part of the female reproductive system that connects the ovaries to the uterus), or peritoneum (the outer covering of the abdominal and pelvic organs).
Elahere is used in adult patients where the cancer cells test positive to folate-receptor alpha (FRα), patients have stopped responding to treatment with platinum-based chemotherapy and they have had one to 3 chemotherapy treatments before.
Ovarian cancer occurs when cells in the ovary, fallopian tube or the peritoneum grow in an abnormal and uncontrolled way.
Elahere is a type of medicine called an antibody drug conjugate. It is made up of an antibody attached to a cancer medicine called DM4. The antibody is a protein that attaches to another protein on the cancer cells known as folate receptor-alpha (FRα). When this happens, Elahere enters the cancer cells and releases the DM4, which kills the cancer cells by stopping their growth.
The effectiveness and safety of Elahere was supported by one main clinical study.
This study compared the effectiveness and safety of Elahere to standard chemotherapy treatments. It included patients with platinum-based chemotherapy resistant ovarian cancer whose cancer had high levels of FRα, and who had already received other chemotherapy treatments.
The study showed a delay in the progression of the cancer and improved overall survival rate of the patients.
Key findings from clinical studies
- Patients given Elahere lived for an average of 5.6 months without the disease getting worse, compared to an average of 4 months for those given standard chemotherapy treatment.
- Patients given Elahere lived longer (around 16.5 months) than those given standard chemotherapy treatment (around 12.8 months).
- The most common side effects of Elahere were blurred vision, keratopathy (damage to the cornea, the clear dome over the coloured part of the eye), abdominal pain and fatigue. For comprehensive information on the potential side effects and risks of Elahere, refer to the Consumer Medicine Information (CMI) leaflet or Product Information (PI) document.
The TGA decided that the application has provided sufficient evidence supporting the safety and effectiveness of Elahere and the medicine can be registered for use in Australia.
More detailed information on why the TGA approved Elahere will be published in the upcoming Australian Public Assessment Report (AusPAR).
The information in this decision summary will not be updated to include any subsequent changes, so may not represent the most current information for a medicine. For current information, refer to the medicine’s CMI or PI.
The CMI leaflet offers guidance for consumers to support safe and effective use of the medicine. The CMI includes information on dose, how to use the medicine properly, potential side effects, safety precautions, storage instructions and more.
The Australian CMI for Elahere can be accessed through the searchable TGA eBusiness Services database.
The PI document provides essential prescribing information for health professionals, including details on dosage recommendations, pregnancy category, contraindications, precautions and potential side effects.
The Australian PI for Elahere can be accessed through the ARTG record or searchable TGA eBusiness Services database.
For health advice and information, including a symptom checker and service finder refer to the healthdirect website.
For advice on prescription medicines, over the counter medicines and other medicines (including complementary medicines) call Medicines Line.
For information on medicines subsidised by the Australian Government refer to the Pharmaceutical Benefits Scheme (PBS) website.
For data and reports on health and welfare topics in Australia refer to the Australian Institute of Health and Welfare website.
An eye examination by an eye care professional is required before a patient begins treatment with Elahere.
Before each infusion of Elahere patients are required to take medications to help prevent infusion related reactions, nausea and vomiting.