FDA Approves Elahere (Mirvetuximab) for Ovarian Cancer

FDA Approval Mirvetuximab Soravtansine: Accelerated OK for Elahere in Ovarian Cancer

The FDA has granted accelerated approval for Mirvetuximab Soravtansine, branded as Elahere, offering new hope for patients with ovarian cancer.

Dr. Sarah Mitchell PharmD, RPh · Senior FDA Regulatory Correspondent

Reviewed by Dr. Sarah Chen Pharmaceutical Sciences Editor

Thursday, April 2, 2026 4 min read Updated Jul 6, 2026

The FDA granted accelerated approval to mirvetuximab soravtansine-gynx (Elahere) on November 14, 2022, for patients with FRα-positive, platinum-resistant ovarian cancer based on SORAYA trial data showing a 31.7% objective response rate.

Key Takeaways

FDA granted accelerated approval to ImmunoGen's Elahere (mirvetuximab soravtansine-gynx) on November 14, 2022
Indicated for FRα-positive, platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer after 1-3 prior systemic regimens
SORAYA trial (NCT04296890) demonstrated 31.7% ORR and 6.9-month median DOR in 106 patients
First FDA-approved ADC for platinum-resistant ovarian cancer; carries boxed warning for ocular toxicity
Companion diagnostic: VENTANA FOLR1 (FOLR1-2.1) RxDx Assay identifies eligible patients

What is Mirvetuximab Soravtansine?

Mirvetuximab soravtansine-gynx (Elahere) is an antibody-drug conjugate (ADC). It pairs a monoclonal antibody that targets folate receptor alpha (FRα) with a toxic drug payload. This design sends chemotherapy straight to cancer cells with high FRα levels. Healthy cells take less damage. Elahere is the first FDA-approved ADC for platinum-resistant ovarian cancer.

What Did the SORAYA Trial Show?

The SORAYA trial (NCT04296890) was a single-arm Phase 3 study. It tested Elahere in 106 patients with FRα-positive, platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer. All patients had prior bevacizumab. About half (51%) had three prior treatment lines. Learn more about other FDA accelerated approvals in oncology.

The trial hit its goal. The investigator-assessed objective response rate (ORR) was 31.7% (95% CI: 22.9-41.6). This included 5 complete responses and 29 partial responses. The median duration of response (DOR) was 6.9 months (95% CI: 5.6-9.7). These findings led to FDA accelerated approval.

Which Patients Qualify for Treatment?

Elahere treats adults with FRα-positive, platinum-resistant ovarian cancer, fallopian tube, or primary peritoneal cancer. Patients must have had one to three prior systemic treatments. Doctors use the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay to find eligible patients. This companion diagnostic from Roche spots tumors with high FRα levels. About 35-40% of ovarian cancer patients show high FRα expression.

What Safety Profile Should Clinicians Know?

Elahere has a boxed warning for eye toxicity. Common side effects include vision problems, keratopathy, fatigue, nausea, stomach pain, and abnormal lab results such as high liver enzymes. In trials, side effects caused dose delays in 33% of patients, dose cuts in 20%, and stopped treatment in 9%.

How Does Accelerated Approval Work?

The FDA used its accelerated approval pathway. This path gives patients earlier access to new therapies for serious diseases. It relies on surrogate endpoints rather than long-term outcomes. Full approval may need proof of clinical benefit from confirmatory trials. The SORAYA trial used tumor response rate and duration of response as its basis for approval.

What is the Confirmatory Trial Status?

The confirmatory MIRASOL trial compares Elahere to investigator's choice chemotherapy. It tests FRα-positive, platinum-resistant ovarian cancer patients. This randomized Phase 3 trial has finished enrollment. It aims to confirm the clinical benefit seen in SORAYA. Results will show if accelerated approval becomes full approval.

What is the Market Significance?

This approval fills a gap in oncology care. It offers the first biomarker-driven targeted therapy for patients with platinum-resistant ovarian cancer. Before Elahere, doctors had only cytotoxic chemotherapy with modest results. The approval marked ImmunoGen's shift to a fully integrated oncology company. It also set a new treatment path for FRα-positive ovarian cancer. See our coverage of other FDA accelerated approvals in oncology.

Elahere Approval Summary
Attribute	Details
Generic Name	Mirvetuximab soravtansine-gynx
Brand Name	Elahere
FDA Approval Date	November 14, 2022
Approval Type	Accelerated Approval
Trial Basis	SORAYA (NCT04296890)
ORR	31.7% (95% CI: 22.9-41.6)
Median DOR	6.9 months (95% CI: 5.6-9.7)
Patient Population	106 FRα-positive, platinum-resistant patients
Companion Diagnostic	VENTANA FOLR1 (FOLR1-2.1) RxDx Assay
Boxed Warning	Ocular toxicity

Frequently Asked Questions

When did the FDA approve mirvetuximab soravtansine-gynx (Elahere)?

The FDA granted accelerated approval to mirvetuximab soravtansine-gynx (Elahere) on November 14, 2022, 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.

What is the SORAYA trial and what were the results?

The SORAYA trial (NCT04296890) was a single-arm Phase 3 study evaluating mirvetuximab soravtansine in 106 patients with FRα-positive, platinum-resistant ovarian cancer. The trial demonstrated an objective response rate (ORR) of 31.7% (95% CI: 22.9-41.6) and a median duration of response (DOR) of 6.9 months (95% CI: 5.6-9.7).

What are the common side effects of Elahere?

Common adverse reactions include ocular toxicities such as keratopathy and blurred vision, fatigue, nausea, abdominal pain, and laboratory abnormalities including increased liver enzymes. Elahere carries a boxed warning for ocular toxicity.

How is patient eligibility determined for Elahere treatment?

Patient eligibility is determined using the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay, a companion diagnostic approved by the FDA to identify patients with FRα-positive tumors who may benefit from Elahere treatment.

What makes Elahere different from other ovarian cancer treatments?

Elahere is the first FDA-approved antibody-drug conjugate (ADC) for platinum-resistant ovarian cancer. It combines a monoclonal antibody targeting folate receptor alpha (FRα) with a cytotoxic maytansinoid payload, delivering targeted chemotherapy directly to tumor cells.

Primary Sources

U.S. Food and Drug Administration. FDA grants accelerated approval to mirvetuximab soravtansine-gynx for FRα-positive platinum-resistant ovarian cancer. November 14, 2022.
ClinicalTrials.gov. SORAYA: A Study of Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer (NCT04296890).
U.S. Securities and Exchange Commission. ImmunoGen, Inc. Press Release: FDA Grants Accelerated Approval of ELAHERE. November 14, 2022.