AstraZeneca, Daiichi's breast cancer drug gets accelerated approval from FDA [Reuters]
DAIICHI SANKYO S/ADR (DSNKY)
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Source: Reuters
AstraZeneca, Daiichi's breast cancer drug gets accelerated approval from FDA Dec 20 (Reuters) - The U.S. Food and Drug Administration said on Friday it had approved Daiichi Sankyo Co Ltd and AstraZeneca Plc’s drug to treat an advanced form of breast cancer, three months ahead of schedule. AstraZeneca in March signed a licensing and collaboration deal that committed the British drugmaker to pay up to $6.9 billion to its Japanese partner Daiichi. ( reut.rs/2sKMyIy ) The drug, Enhertu, comes with a boxed warning, the FDA’s strictest warning, flagging increased risk of lung disease and embryo-fetal toxicity. The agency said further clinical trials may be required to verify and describe the benefits of Enhertu, which is still under development. Enhertu, also known as DS-8201, targets HER2 protein, a major trigger of uncontrolled cell growth in about 20% cases of breast cancer, where Roche Holding AG has been a pioneer with its aging $7 billion-a-year best-seller Herceptin. The FDA’s accele
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