New Treatment for Platinum-Resistant Ovarian Cancer

In a significant development for the treatment of platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, on March 22, 2024 the Food and Drug Administration (FDA) granted approval for mirvetuximab soravtansine-gynx, marketed as Elahere by ImmunoGen, Inc. (now a part of AbbVie). This approval is specifically for adult patients who have received one to three prior systemic treatment regimens and have tested positive for FRα expression, as determined by an FDA-approved test. 

The approval follows the successful evaluation of mirvetuximab soravtansine-gynx in Study 0416 (MIRASOL), a comprehensive clinical trial involving 453 patients. In this multicenter, open-label study, patients received either mirvetuximab soravtansine-gynx or investigator’s choice of chemotherapy until disease progression or unacceptable toxicity. The results demonstrated significant improvements in overall survival (OS), progression-free survival (PFS), and overall response rate (ORR) compared to chemotherapy alone. 

Key Findings from Study 0416 

• Median OS was 16.5 months with mirvetuximab soravtansine-gynx compared to 12.7 months with chemotherapy. 
• Median PFS was 5.6 months with mirvetuximab soravtansine-gynx compared to 4.0 months with chemotherapy. 
• The ORR was 42% with mirvetuximab soravtansine-gynx compared to 16% with chemotherapy. 

However, it’s essential to note that mirvetuximab soravtansine-gynx comes with certain risks, including ocular toxicity, pneumonitis, peripheral neuropathy, and embryo-fetal toxicity. These risks are outlined in the prescribing information, which also includes a Boxed Warning. 

Next Steps 

Healthcare professionals should familiarize themselves with the prescribing information, including dosing recommendations and safety precautions. Patients who may be eligible for treatment with mirvetuximab soravtansine-gynx should discuss this option with their healthcare provider. 

As with any medication, it’s crucial to report any adverse events or concerns to the FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088. This ensures ongoing monitoring of the drug’s safety and efficacy. 

Conclusion 

The approval of mirvetuximab soravtansine-gynx represents a significant advancement in the treatment landscape for platinum-resistant ovarian cancer, offering new hope for patients facing this challenging condition. Stay informed as further updates on this groundbreaking therapy unfold. 

Read the FDA announcement here.