FDA Approves ELAHERE for Ovarian Cancer

The American Cancer Society states that ovarian cancer is the fifth leading cause of cancer-related death in women in the United States. The organization also says that, in 2022, nearly 13,000 people in the US with female reproductive anatomy will die from ovarian cancer. The FDA recently granted ImmunoGen accelerated approval of ELAHERE for platinum-resistant ovarian cancer, offering clinicians an additional tool to treat the potentially deadly disease.

ELAHERE is composed of mirvetuximab soravtansine-gynx, an antibody–drug conjugate. This approval is based on results from the SORAYA trial, which recruited 106 participants with platinum-resistant ovarian cancer who had received between one and three prior systemic treatments, including Avastin. This study's primary and secondary endpoints were objective response rate (ORR) and duration of response (DOR), respectively.

According to the press release, “ELAHERE demonstrated an ORR by the investigator of 31.7% (95% confidence interval [CI]: 22.9, 41.6), including five complete responses (CRs). The median DOR was 6.9 months (95% CI: 5.6, 9.7) as assessed by the investigator.”

Despite the medication's approval and perceived benefits, the drug has some side effects. Side effects include ocular toxicity and visual impairments. Common adverse effects include but are not limited to laboratory abnormalities, fatigue, nausea, increased alanine aminotransferase, keratopathy, abdominal pain, decreased lymphocytes, peripheral neuropathy, diarrhea, decreased albumin, constipation, increased alkaline phosphatase, dry eye, decreased magnesium, decreased leukocytes, decreased neutrophils, and decreased hemoglobin. These side effects were experienced in over 19% of participants.

"Platinum-resistant ovarian cancer is a notoriously challenging disease to treat. Given there have been no new therapies approved by FDA for this indication since 2014, ELAHERE's accelerated approval is a tremendous advance in the ovarian cancer treatment paradigm,” said Anna Berkenblit, MD, Senior Vice President and Chief Medical Officer of ImmunoGen, in the press release. “We are thrilled with today’s approval and extend our sincere thanks to the patients, families, caregivers, and investigators who helped make this achievement a reality and have supported the broader mirvetuximab development program. As we work to deliver more good days to patients, we look forward to the continued evaluation of mirvetuximab in earlier lines of treatment, in combination, and across a wider range of levels of FRα expression.”

Continued, full approval and use of the medication is contingent on the results of MIRASOL; a confirmatory clinical trial intended to yield results in the coming year.