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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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.
Emerging Company Profile: Using IP licensed from Yale, Kleo is betting it can complement or replace existing immuno-oncology drugs, specifically Darzalex. In partnership with PeptiDream, it just unveiled its first candidate for clinical development.