Imbruvica-next big drug in B-cell cancer-approved by FDA

摘要

The US Food and Drug Administration (FDA) has granted accelerated approval to Pharmacyclics' first-in-class, irreversible Bruton's tyrosine kinase (BTK) inhibitor Imbruvica (ibrutinib), to treat mantle cell lymphoma (MCL), a rare and aggressive form of non-Hodgkin's lymphoma. The approval, intended for patients with at least one prior therapy, came last November just four months after the drug was filed and a short four years after it first entered clinical trials.