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AstraZeneca's non-small cell lung cancer drug wins approval in US
StockMarketWire.com
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Pharmaceutical giant AstraZeneca said its non-small cell lung cancer drug had been approved in the US.
Tagrisso, used to treat early-stage epidermal growth factor receptor-mutated non-small cell lung cancer patients was granted approval under the US Food and Drug Administration's real-time oncology review pilot program.
Five other countries participated in a concurrent submission and review process through FDA's project Orbis.
'This approval dispels the notion that treatment is over after surgery and chemotherapy, as the ADAURA results show that Tagrisso can dramatically change the course of this disease,' the company said.
In a separate statement, AstraZeneca said the US Food and Drug Administration had requested further clarifying analyses of clinical data, to complete its review of the new drug application for roxadustat to treat patients with anemia of chronic kidney disease.
The new drug application remained under regulatory review, with the FDA having set a new action date of 20 March 2021.
'AstraZeneca and FibroGen (FibroGen) are committed to working with the FDA and have agreed to submit the additional clarifying analyses as soon as possible to assist with the completion of labelling discussions,' it added.
Story provided by StockMarketWire.com
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