FDA Approves First-Ever ADC in Platinum-Resistant Ovarian Cancer (Updated)

2022-11-15

上市批准加速审批临床结果

Sarah Silbiger/Getty Images The FDA has signed off on ImmunoGen’s Elahere (mirvetuximab soravtansine-gynx) for platinum-resistant ovarian cancer, making it the first antibody-drug conjugate approved for this indication. Elahere was approved under the Agency’s accelerated pathway and applies to adult patients with folate receptor alpha-positive ovarian, fallopian tube or primary peritoneal cancers who have received one to three previous lines of systemic therapy. MIRASOL, a confirmatory trial to convert Elahere’s accelerated to full approval, is now fully enrolled, ImmunoGen reported. Initial readouts are expected early next year. During a conference call Tuesday morning, ImmunoGen president and CEO Mark Enyedy said the company will also continue to investigate Elahere in platinum-sensitive disease. Elahere comes with a boxed warning, calling the attention of physicians and patients to possible ocular toxicities such as dry eye, uveitis and visual impairments. The most common adverse reactions associated with Elahere included laboratory abnormalities, fatigue, diarrhea and abdominal pain, and the ocular side effects listed in the label. Data from the pivotal SORAYA trial formed the basis for Elahere’s accelerated approval. With over 100 patients enrolled, SORAYA was a single-arm study assessing the objective response rate and duration of response after Elahere treatment. Overall, 31.7% of patients responded to Elahere treatment, including five complete responders, lasting for a median duration of 6.9 months. All participants in SORAYA had previously been treated with Genentech’s Avastin (bevacizumab). During the call, Enyedy said the FDA’s label allows Elahere treatment regardless of prior Avastin treatment, which effectively “doubles the eligible patient population relative to the SORAYA eligibility criteria.” Alongside Elahere’s regulatory go-ahead, the FDA has also approved the Roche's VENTANA FOLR1 (FOLR1-2.1) RxDx Assay, a companion diagnostic test to identify patients eligible to receive Elahere. A Much-Needed Win for Ovarian Cancer In a statement, Anna Berkenblit, M.D., senior vice president and chief medical officer of ImmunoGen, said Monday’s approval was a “tremendous advance in the ovarian cancer treatment paradigm,” for which no treatment has been approved since 2014. Elahere’s approval also comes amid increasing restrictions on PARP inhibitors PARP inhibitors, a popular treatment class for ovarian cancer. Last week, at the request of the FDA, GSK limited the use of Zejula (niraparib) only to patients with deleterious or suspected deleterious germline BRCA mutations. GSK had already withdrawn Zejula as a fourth-line treatment for advanced ovarian, fallopian tube or primary peritoneal cancers. Aside from GSK, AstraZeneca has also suffered setbacks in ovarian cancer, with its PARP inhibitor PARP inhibitor Lynparza losing its indication in advanced ovarian cancer patients with BRCA mutations. In June, Clovis Oncology pulled Rubraca (rucaparib) from the U.S. market, no longer offering the drug as a treatment option for patients with BRCA-mutated ovarian cancer who had been treated with at least two previous lines of chemo. The Colorado-based company warned of potential bankruptcy earlier this month.

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