Key Summary
MHRA approves mirvetuximab soravtansine for certain advanced ovarian cancers
It targets cancer cells and delays disease progression better than standard chemo
Side effects exist; MHRA will monitor safety via the Yellow Card scheme
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a cutting-edge drug, mirvetuximab soravtansine (Elahere) yesterday, to treat ovarian cancer, fallopian tube cancer and primary peritoneal cancer in adults.
The medicine is approved via the International Recognition Procedure (IRP), for patients who have a protein named folate receptor-alpha (FRα) on the surface of their cancer cells.
Mirvetuximab soravtansine is created out of a monoclonal antibody that identifies and attaches itself to FRα protein on the cancer cells.
Post this, it discharges the cancer medicine DM4 that kills the cancer cells.
The new drug is for patients who did not respond to, or have stopped responding to, platinum-based chemotherapy, and have already undergone one to three previous treatments.
The drug is administered as intravenous infusion (into vein) in the form of a concentrated solution.
An experience doctor or nurse will provide the medication in appropriate doses and cycles based on the patient’s body weight.
The approval of the drug comes on the back of a study consisting of 453 adults who suffer advancer platinum-resistant cancers of ovary, fallopian tube and the peritoneum with positive FRα.
A comparison of mirvetuximab soravtansine and the standard chemotherapy was conducted during the study.
The results of the experiment showed that the patients who were administered with the lived longer without the worsening of the disease.
Patients who received mirvetuximab soravtansine lived on average for around 5.6 months without their disease getting worse while those who received standard treatment lived for around 4 months without their disease getting worse.
However, mirvetuximab soravtansine comes with side effects as well.
Blurred vision, nausea, diarrhea, tiredness, abdominal pain, vomiting, decreased apetite, peripheral neuropathy, etc. are some of the common side effects of it.
The MHRA will closely monitor the safety and effectiveness of mirvetuximab soravtansine.
Anyone experiencing side effects should speak to a doctor, pharmacist, or nurse and report them via the Yellow Card scheme or via the MHRA Yellow Card app.
“We are committed to making innovative treatment options, like mirvetuximab soravtansine, the first and only folate receptor-alpha (FRα) directed antibody drug conjugate, available to patients as quickly as possible, ensuring our approval is underpinned by robust evidence of efficacy alongside the highest standards of safety,” said Julian Beach, MHRA interim executive director, Healthcare Quality and Aceess.
He reiterated that all the drugs even after their approval will be under the close watch of MHRA to ensure the best of safety.
