Genmab and Janssen's Darzalex gets new FDA Breakthrough designation
The US Food and Drug Administration has granted new Breakthrough therapy designation for Darzalex (daratumumab) as a treatment for previously treated multiple myeloma in combination with standard of care regimens.
Darzalex is being developed by Janssen Biotech, a subsidiary of US healthcare giant Johnson & Johnson (NYSE: JNJ), under a worldwide development and commercialization licensing agreement from Danish biotech Genmab (OMX: GEN).
Genmab’s share price rose by 4.89% on Tuesday morning, when news of the new designation was announced. This has been granted for the use of Darzalex in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.
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