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FDA expands AstraZeneca's Datroway label, making it the first TROP2-directed lung cancer therapy approved in the United States.
AstraZeneca PLC (LSE:AZN) has scored another significant milestone in its cancer treatment programme, securing accelerated approval from the US Food and Drug Administration (FDA) for Datroway, a promising drug aimed at treating advanced lung cancer. According to analysts at Shore Capital, this marks a notable step forward, even though the approval initially targets a smaller patient group than anticipated.
The drug was approved to treat patients who have already received chemotherapy under an accelerated approval process after a Phase 2 trial. The approval was also supported by data from a Phase 3 trial.
AstraZeneca said on Tuesday that U.S. regulators have approved its precision drug Datroway to treat a type of lung cancer, adding that the drugmaker would now pay partner Daiichi Sankyo $45 million in milestone-related considerations.
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Shares in AstraZeneca PLC (LSE:AZN), the largest company on the FTSE 100 index, and fellow blue chip GSK PLC (LSE:GSK, NYSE:GSK) were down 1.4% and 1.9% respectively on renewed worries about US drug tariffs. The pharmaceutical pair were a large drag on the London index after US President Donald Trump said tariffs on imported drugs could be imposed “very soon”, echoing comments from two months ago.
Astrazeneca (AZN) concluded the recent trading session at $73.55, signifying a -1.17% move from its prior day's close.