Roche: FDA extends review period for lung cancer drug
(CercleFinance.com) - Roche has said that the US health regulators have extended the review period for Tecentriq in the first-line treatment of metastatic non-squamous non-small cell lung cancer by three months.
The Swiss drugmaker said it was notified by the US Food and Drug Administration that the extension would allow time to review additional information requested in support of the application.
The FDA is now expected to make a decision on approval by 5 December.
In May 2018, Tecentriq in combination with Avastin, carboplatin and paclitaxel was granted priority review from the FDA for the initial treatment of people with metastatic non-squamous non-small cell lung cancer, based on positive results from a Phase III study.
The Zurich-listed Roche stock is currently down 0.5% after the delay was announced.
Copyright (c) 2018 CercleFinance.com. All rights reserved.
The Swiss drugmaker said it was notified by the US Food and Drug Administration that the extension would allow time to review additional information requested in support of the application.
The FDA is now expected to make a decision on approval by 5 December.
In May 2018, Tecentriq in combination with Avastin, carboplatin and paclitaxel was granted priority review from the FDA for the initial treatment of people with metastatic non-squamous non-small cell lung cancer, based on positive results from a Phase III study.
The Zurich-listed Roche stock is currently down 0.5% after the delay was announced.
Copyright (c) 2018 CercleFinance.com. All rights reserved.