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FDA grants accelerated approval to mirvetuximab soravtansine-gynx for ovarian cancer

This is the first FDA-approved ADC for platinum-resistant disease, according to ImmunoGen.

ImmunoGen recently announced that the US Food and Drug Administration has granted accelerated approval to the company’s first-in-class antibody-drug conjugate (ADC), mirvetuximab soravtansine-gynx (ELAHERE).

ELAHERE is now approved for the treatment of adults with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have also received 1-3 prior systemic treatments.

Accelerated approval of ELAHERE is based on objective response rate (ORR) and duration of response (DOR) data from the SORAYA trial. Notably, continued approval may be contingent upon results in a confirmatory trial.

In a single-arm study within the SORAYA trial, ELAHERE was investigated in 106 patients with platinum-resistant ovarian cancer, had tumors with high levels of FRα, and who had been treated with 1-3 systemic treatment regimens prior to the study.

The primary endpoint included confirmed ORR as observed by an investigator and the secondary endpoint was DOR.

In the study, ELAHERE showed an ORR of 31.7% (95% confidence interval [CI]: 22.9, 41.6), as well as 5 complete responses (CRs). Also, the median DOR was 6.9 months (95% CI: 5.6, 9.7).

As for the safety of ELAHERE, the drug has been assessed in a pooled analysis from 3 studies, totaling 464 patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who received at least 1 dose of ELAHERE.

Common adverse reactions included increased aspartate aminotransferase, laboratory abnormalities, vision impairment, diarrhea, decreased albumin, abdominal pain, fatigue, nausea, keratopathy, decreased lymphocytes, peripheral neuropathy, constipation, dry eye, decreased magnesium, increased alkaline phosphatase, decreased neutrophils, decreased leukocytes, and decreased hemoglobin.

Additionally, ELAHERE includes a boxed warning within the prescribing information for ocular toxicity, such as visual impairment, photophobia, eye pain, keratopathy, dry eye, and uveitis.

"The approval of ELAHERE is significant for patients with FRα-positive platinum-resistant ovarian cancer, which is characterized by limited treatment options and poor outcomes,"

said Ursula Matulonis, MD, chief of the Division of Gynecologic Oncology at the Dana-Farber Cancer Institute, professor of medicine at Harvard Medical School, and SORAYA coprincipal investigator. “ELAHERE’s impressive anti-tumor activity, durability of response, and overall tolerability observed in SORAYA demonstrate the benefit of this new therapeutic option, and I look forward to treating patients with ELAHERE."

Reference:

ImmunoGen Announces FDA Accelerated Approval of ELAHERE™ (mirvetuximab soravtansine-gynx) for the Treatment of Platinum-Resistant Ovarian Cancer. Immunogen. November 14, 2022. Accessed November 17, 2022. https://investor.ImmunoGen.com/news-releases/news-release-details/immunogen-announces-fda-accelerated-approval-elaheretm