The FDA designates AstraZeneca's (AZN -0.6%) acalabrutinib a Breakthrough Therapy for the treatment of patients with mantle cell lymphoma who have received at least one prior line of therapy. A Phase 2 clinical trial is in process.
Breakthrough Therapy status provides for more intensive guidance from the FDA, the involvement of more senior agency personnel and a rolling review of the marketing application.
Acalabrutinib (ACP-196) is an orally available second generation inhibitor of an enzyme called Bruton's tyrosine kinase (BTK) that is in development for the treatment of a range of cancers.
AstraZeneca secured the rights via its acquisition of a majority stake in Dutch biotch Acerta Pharma in 2016.
Previously: AstraZeneca completes $4B Acerta Pharma transaction (Feb. 2, 2016)
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