FDA Grants Blincyto Accelerated Approval Based On MRD Response Endpoint
Amgen sees the approval as a platform to expand blinatumomab into other hematologic malignancies using similar approaches.
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Immuno-oncology is a key area for biological drug development and activity has exploded over the past decade. Today, IO therapies represent a third of the biologics pipeline, and antibody development remains the focus.
Phase III study in newly diagnosed patients with NPM1-mutated AML could enable Kronos’ SYK-inhibitor to reach market two years earlier under accelerated approval than it would under a traditional endpoint, company says.
The companies are combining their technologies to seek neutralizing antibody therapeutics that could prevent or treat COVID-19, building on their previous partnership in monitoring minimal residual disease in blood cancers.