The approval was based on the findings from the confirmatory Phase 3 MIRASOL trial in which Elahere treatment reduced the risk of cancer progression by 35%
AbbVie secures FDA full approval for Elahere in platinum-resistant ovarian cancer. (Credit: AbbVie Inc.)
AbbVie has received the US Food and Drug Administration’s (FDA) full approval for Elahere (mirvetuximab soravtansine-gynx) to treat certain ovarian cancer patients.
Elahere is a first-in-class antibody-drug conjugate (ADC) designed to kill the targeted cancer cells.
AbbVie added the cancer drug candidate to its portfolio through its acquisition of ImmunoGen, which closed last month. Elahere received FDA accelerated approval in November 2022.
The approval is for the treatment of adult patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal adult cancer patients.
These individuals must have received one to three prior systemic treatment regimens.
AbbVie secured the full approval based on the findings from the confirmatory Phase 3 MIRASOL trial.
The multicentre, open-label, active-controlled, randomised, two-arm trial study compared the drug against investigator’s choice (IC) of chemotherapy in 453 patients with platinum-resistant ovarian cancer (PROC).
The trial recruited patients whose tumours were positive for FRα expression as confirmed by the VENTANA FOLR1 RxDx Assay.
The study participants were randomised 1:1 to get either mirvetuximab soravtansine 6mg/kg through intravenous (IV) infusion every three weeks or IC of chemotherapy, until disease progression or unacceptable toxicity.
The primary endpoint was defined as progression-free survival (PFS) by investigator assessment. On the other hand, key secondary endpoints included objective response rate (ORR) and overall survival (OS).
According to the results, the cancer therapy showed an OS hazard ratio (HR) of 0.67, demonstrating a 33% reduction in death risk in the Elahere arm in comparison to the IC chemotherapy group.
In addition, the PFS HR was 0.65, which was equivalent to a 35% decrease in the tumour risk or cancer progression in the Elahere arm against the IC chemotherapy.
AbbVie global therapeutics chief medical officer and senior vice president Roopal Thakkar said: “The full FDA approval of Elahere for eligible patients with ovarian cancer represents the culmination of years of work by the ImmunoGen team.
“Elahere is the first and only antibody-drug conjugate (ADC) approved in the U.S. for this difficult-to-treat malignancy.”