FDA Approves Mirvetuximab Soravtansine-gynx for Ovarian Cancer
On March 22, 2024, the FDA approved mirvetuximab soravtansine-gynx (Elahere) for adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens[1]. Patients are selected for treatment based on an FDA-approved test[1].
Mirvetuximab soravtansine-gynx is an antibody-drug conjugate that targets folate receptor alpha (FRα), which is overexpressed in many epithelial ovarian cancers[2]. The drug consists of a folate receptor-binding antibody linked to a potent tubulin-disrupting agent called DM4[2]. By selectively delivering the cytotoxic payload to FRα-expressing tumor cells, mirvetuximab soravtansine aims to maximize anti-tumor activity while minimizing systemic exposure and toxicity[2].
The approval was based on results from the SORAYA trial, which enrolled 106 patients with platinum-resistant ovarian cancer and high FRα expression[1]. Patients received mirvetuximab soravtansine-gynx monotherapy until disease progression or unacceptable toxicity[1]. The confirmed objective response rate was 32.1%, with a median duration of response of 6.9 months[1].
“The FDA approval of Elahere represents an important new treatment option for patients with platinum-resistant ovarian cancer, a disease with significant unmet need,” said Dr. Ursula Matulonis, Chief of the Division of Gynecologic Oncology at Dana-Farber Cancer Institute[2]. “Elahere’s targeted mechanism of action and clinically meaningful responses in heavily pretreated patients make it a valuable addition to our therapeutic arsenal against this challenging malignancy.”
The development of mirvetuximab soravtansine-gynx highlights the growing importance of precision oncology, where treatments are matched to specific molecular targets and patient populations[4]. By focusing on FRα, a marker expressed in the majority of ovarian cancers, this antibody-drug conjugate has the potential to benefit many women with this devastating disease[2].
As the oncology field continues to advance, targeted therapies like mirvetuximab soravtansine-gynx will play an increasingly central role in cancer care[4]. This FDA approval represents an important milestone in the ongoing effort to improve outcomes for patients with platinum-resistant ovarian cancer.
Citations:
[1] https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications
[2] https://www.proclinical.com/blogs/2024-5/5-recent-fda-oncology-approvals-that-could-change-the-future
[3] https://www.cancer.gov/news-events/cancer-currents-blog?page=1&topic=fda-approvals
[4] https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2787092
[5] https://www.health.harvard.edu/blog/fda-approves-new-treatment-for-advanced-prostate-cancer-202307122952