FDA yesterday granted accelerated approval for mirvetuximab soravtansine-gynx (Elahere, Immunogen) for the treatment of adult patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received 1 to 3 prior systemic treatment regimens. The accelerated approval was based on objective response rate and duration of response data from the pivotal SORAYA trial. The product is a first-in-class antibody-drug conjugate (ADC) directed against FRα, a cell-surface protein highly expressed in ovarian cancer, and is the first FDA-approved ADC for platinum-resistant disease.
Both of Moderna’s bivalent omicron-targeting booster candidates (mRNA-1273.214 and mRNA-1273.222) triggered a superior antibody response against omicron (BA.4/BA.5) in phase 2/3 clinical trials, the company said yesterday, compared with a booster dose of mRNA-1273. Both bivalent booster candidates also met noninferiority immunogenicity criteria with respect to the original strain. Interim results from the phase 2/3 trial were published last month in the New England Journal of Medicine.