The new drug, mirvetuximab soravtansine-gynx (Elahere), is cleared for some patients who have what’s known as epithelial ovarian cancer (the most common form of these malignancies according to MedlinePlus), as well as cancers in the fallopian tubes and peritoneum, a delicate membrane that covers the abdominal walls, uterus, bladder, and rectum. Elahere is approved only for patients with a specific type of cancer known as folate receptor alpha-positive platinum-resistant disease who have previously received so-called systemic treatments like chemotherapy, immunotherapy, or hormone therapy, the FDA said in a statement. Separately, the FDA approved a diagnostic test that can identify patients with tumors that fit this exact profile. “Platinum-resistant ovarian cancer is a notoriously challenging disease to treat,” said Anna Berkenblit, MD, the senior vice president and chief medical officer of the drugmaker ImmunoGen, developer of Elahere, in a statement. “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.” Ovarian cancer is the leading cause of death from gynecological cancers in the United States, according to the American Cancer Society. Each year, about 20,000 patients are diagnosed with these tumors and about 13,000 die from this disease. Most of the time, it’s caught when tumors are advanced, and most people have a poor prognosis even after treatment with surgery and chemotherapy. Many people eventually develop ovarian tumors that don’t respond to two commonly used chemotherapies — cisplatin and carboplatin — and are then considered “platinum-resistant” tumors, per the National Cancer Institute. In a pivotal clinical trial, scientists tested Elahere in 106 patients who took the cancer therapy bevacizumab (Avastin) and up to three different treatment regimens with systemic therapy. All the trial participants had a diagnostic test to confirm they had folate receptor alpha-positive platinum-resistant disease. Then they all received intravenous infusions of Elahere every three weeks until either their tumors started growing again or side effects prompted them to stop. Overall, 31.7 percent of patients responded to treatment. Most of these cases involved a partial response to treatment, meaning tumors shrank or the amount of cancer in the body decreased. This group did include five people who had a complete response, meaning all signs of cancer in the body disappeared during the trial. The median duration of patients’ response to treatment was 6.9 months, the FDA said. At least 20 percent of patients taking Elahere experienced side effects such as vision impairment, fatigue, nausea, abdominal pain, tingling or loss of sensation in the hands and feet, diarrhea, constipation, and dry eye. Regulators issued a boxed warning — reserved for serious side effects — about the potential for issues related to the eyes, which impacted 61 percent of patients who took Elahere. These ocular side effects included vision impairment, cornea disease, dry eye, sensitivity to light, and inflammation of tissue in the eye wall. Patients who take Elahere should get regular eye exams during treatment. Survival rates for ovarian cancer vary with the type of tumor and how soon it’s detected, according to the American Cancer Society. People with epithelial ovarian cancer have five-year survival rates of 93 percent when tumors are caught early, but only 31 percent when tumors have already spread to other parts of the body.
