AstraZeneca: FDA's priority review for blood cancer drug.
(CercleFinance.com) - AstraZeneca said on Wednesday that the US Food and Drug Administration (FDA) has granted priority review to an experimental blood cancer drug developed by its Acerta Pharma unit.
AstraZeneca and its haematology research and development division said the FDA has accepted and granted priority review for the new drug application (NDA) for acalabrutinib.
The FDA's decision is based on results from a phase II clinical trial, which assessed the safety and efficacy of acalabrutinib in patients with relapsed/refractory mantle cell lymphoma (MCL), the drugmaker said.
Priority review is granted to applications for medicines that, if approved, would offer a significant improvement in the treatment of serious conditions.
In this case, the action date has been set for the first quarter of 2018.
Copyright (c) 2017 CercleFinance.com. All rights reserved.
AstraZeneca and its haematology research and development division said the FDA has accepted and granted priority review for the new drug application (NDA) for acalabrutinib.
The FDA's decision is based on results from a phase II clinical trial, which assessed the safety and efficacy of acalabrutinib in patients with relapsed/refractory mantle cell lymphoma (MCL), the drugmaker said.
Priority review is granted to applications for medicines that, if approved, would offer a significant improvement in the treatment of serious conditions.
In this case, the action date has been set for the first quarter of 2018.
Copyright (c) 2017 CercleFinance.com. All rights reserved.