Elahere Gets Full FDA Approval for Pretreated Gynecologic Cancer

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The Food and Drug Administration granted a full approval to Elahere for the treatment of certain patients with platinum-resistant gynecologic cancers.

The Food and Drug Administration (FDA) granted a full approval to Elahere (mirvetuximab soravtansine –gynx) for the treatment of patients with previously treated folate receptor α (FRα)–positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer, according to the agency.

“[Elahere] is really an important medication for patients. It gives them another option, based upon the biomarker — since it’s a biomarker-driven therapy — and it's an effective therapy and now [proven] through [the] MIRASOL [trial]. It's been shown to be better than chemotherapy,” Dr. Ursula A. Matulonis, Chief of the Division of Gynecologic Oncology at the Dana-Farber Cancer Institute and Professor of Medicine at Harvard Medical School, said in an interview with CURE.

The drug was granted an accelerated approval in November 2022, with the full approval contingent upon further data from the phase 3 MIRASOL trial, which compared Elahere to standard-of-care chemotherapy in 453 patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer who underwent one to three prior lines of therapy.

“The full approval is based upon the phase 3 MIRASOL study, showing really remarkable results of [Elahere]versus investigators’ choice chemotherapy in a very hard-to-treat patient population, where chemotherapy response rates are 10% or less with very short progression-free survival rates,” Matulonis said.

Data from MIRASOL showed that patients given Elahere tended to have improved overall survival (time patients live before death of any cause) and progression-free survival (time patients live before their disease worsens). Specifically, median overall survival was 16.5 months in the Elahere group, compared with 12.7 months in the chemotherapy group. Median progression-free survival was 5.6 months versus four months, in the Elahere and chemothearpy groups, respectively.

The most common side effects — including laboratory abnormalities — that occurred in 20% or more of patients given Elahere were increased aspartate aminotransferase, fatigue, increased alanine aminotransferase, blurred vision, nausea, increased alkaline phosphatase, diarrhea, abdominal pain, keratopathy, peripheral neuropathy, musculoskeletal pain, decreased lymphocytes, decreased platelets, decreased magnesium, decreased hemoglobin, dry eye, constipation, decreased leukocytes, vomiting, decreased albumin, decreased appetite and decreased neutrophils.

The drug also comes with a Boxed Warning for ocular (eye-related) toxicity.

Regarding eye toxicity, Matulonis explained, “most of the time is blurred vision. So, it's just that they may have more difficulty reading. It's not blindness, it's blurred vision.”

Patients who experience blurred vision should not only work with an eye specialist during their Elahere treatment, but they should also be sure to bring up their side effects with their oncologist, too, as they may benefit from a decreased dosing schedule, explained Matulonis.

“Thankfully, the cornea is able to repair itself pretty quickly, within a matter of weeks. So, if the blurred vision is clinically significant, patients bothered by it, one can pull the dosing and or lower the dose from six down to five,” she said. “We know that the based upon you know the modeling of the dosing, that dropping from six down to five does not alter efficacy.”

Unlike other cancer-treatments, Matulonis explained, Elahere has “no ill effects [regarding] cardiac or renal toxicity.”

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