Roche: FDA approval in lung cancer
(CercleFinance.com) - Roche announced that the US FDA has approved Tecentriq as an adjuvant treatment, following surgery and platinum-based chemotherapy, for certain adult patients with stage II-IIIA non-small cell lung cancer (NSCLC).
The approval is based on an interim analysis of the phase III IMpower010 study, showing that adjuvant Tecentriq improved disease-free survival by over one-third in PD-L1-positive stage II-IIIA NSCLC, compared to best supportive care.
The review of this application was conducted under the FDA's Project Orbis initiative, which provides a framework for the simultaneous submission and review of oncology drugs with other international regulators.
Copyright (c) 2021 CercleFinance.com. All rights reserved.
The approval is based on an interim analysis of the phase III IMpower010 study, showing that adjuvant Tecentriq improved disease-free survival by over one-third in PD-L1-positive stage II-IIIA NSCLC, compared to best supportive care.
The review of this application was conducted under the FDA's Project Orbis initiative, which provides a framework for the simultaneous submission and review of oncology drugs with other international regulators.
Copyright (c) 2021 CercleFinance.com. All rights reserved.