AstraZeneca: priority review for Calquence in US
(CercleFinance.com) - AstraZeneca announced on Thursday that the US FDA has granted priority review to its Calquence tablet for the treatment of mantle cell lymphoma, a rare form of non-Hodgkin's malignant lymphoma.
The pharmaceutical group points out that the agency's decision was based on the results of a Phase III clinical study showing that Calquence-based treatment reduced the risk of disease progression or death by 27% compared to conventional chemotherapy.
A 'priority review' means that the FDA aims to rule on an application for approval in around six months, suggesting a possible approval in Q1 2025.
Mantle cell lymphoma, a blood cancer that affects B lymphocytes located in the 'mantle zone' of lymph nodes, affects around 27,500 worldwide, AstraZeneca says.
Calquence is a selective inhibitor of Bruton's tyrosine kinase (BTK) which binds to BTK and neutralises its activity, with minimal interference to other immune cells.
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The pharmaceutical group points out that the agency's decision was based on the results of a Phase III clinical study showing that Calquence-based treatment reduced the risk of disease progression or death by 27% compared to conventional chemotherapy.
A 'priority review' means that the FDA aims to rule on an application for approval in around six months, suggesting a possible approval in Q1 2025.
Mantle cell lymphoma, a blood cancer that affects B lymphocytes located in the 'mantle zone' of lymph nodes, affects around 27,500 worldwide, AstraZeneca says.
Calquence is a selective inhibitor of Bruton's tyrosine kinase (BTK) which binds to BTK and neutralises its activity, with minimal interference to other immune cells.
Copyright (c) 2024 CercleFinance.com. All rights reserved.