Roche: lung cancer immunotherapy gets FDA priority review
(CercleFinance.com) - US health regulators have granted a priority review for a Roche cancer immunotherapy, which improved the survival of patients with extensive-stage small cell lung cancer in clinical trials.
The US Food and Drug Administration has granted priority review for Tecentriq, in combination with chemotherapy, for the initial treatment of people with extensive-stage small cell lung cancer.
In a phase III trial, the Tecentriq-based combination significantly reduced the risk of disease worsening or death compared with chemotherapy alone.
A priority review designation is granted to medicines that the FDA has determined as having the potential to provide significant improvements in the treatment, prevention or diagnosis of a serious disease.
The FDA is expected to make a decision on approval by 18 March 2019, Roche said.
Copyright (c) 2018 CercleFinance.com. All rights reserved.
The US Food and Drug Administration has granted priority review for Tecentriq, in combination with chemotherapy, for the initial treatment of people with extensive-stage small cell lung cancer.
In a phase III trial, the Tecentriq-based combination significantly reduced the risk of disease worsening or death compared with chemotherapy alone.
A priority review designation is granted to medicines that the FDA has determined as having the potential to provide significant improvements in the treatment, prevention or diagnosis of a serious disease.
The FDA is expected to make a decision on approval by 18 March 2019, Roche said.
Copyright (c) 2018 CercleFinance.com. All rights reserved.