AbbVie scores full approval for ImmunoGen ADC programme in ovarian cancer

2024-03-22

临床结果上市批准临床3期并购优先审批

On Friday, the FDA granted full approval to AbbVie’s Elahere (mirvetuximab soravtansine-gynx) to treat certain patients with ovarian cancer. The pharma gained the antibody-drug conjugate (ADC) through its $10.1-billion acquisition of ImmunoGen, which closed in February.

The greenlight, which comes two weeks ahead of the FDA’s decision deadline, converts a 2022 accelerated approval for Elahere to treat patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received up to three prior therapies.

The accelerated approval was based on results from the Phase III SORAYA trial, in which Elahere achieved an objective response rate (ORR) of about 32%. Friday’s full approval – and the ADC’s priority review – were triggered by a positive readout from the Phase III MIRASOL trial in May.

The confirmatory study randomised 453 patients to receive either Elahere or investigator's choice of chemotherapy. For the primary endpoint of progression-free survival (PFS), the ADC led to a 35% reduction in the risk of tumour progression or death versus chemotherapy. Additionally, on the key secondary goal of overall survival (OS), Elahere reduced the risk of death by 33% versus chemotherapy.

“Elahere provides an effective new option for patients with FRα-positive tumours FRα-positive tumours. These patients previously had very limited options and Elahere changes that," said Kathleen Moore, a principal investigator for the MIRASOL study.

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