Tag: Daiichi Sankyo

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Quizartinib Vanflyta-Daiichi-Sankyo
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Quizartinib is approved by the FDA for newly diagnosed acute myeloid leukemia

August 2023: The treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) that is FLT3 internal tandem duplication (ITD)-positive, as detected by an FDA-approved test, with standard cytarabine and anthracycl..

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Accelerated approval is granted by FDA to fam-trastuzumab deruxtecan-nxki for HER2-mutant non-small cell lung cancer

August 2022: For adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have a mutation resulting in mesenchymal-epithelial transition (MET) exon 14 skipping, as detected by an FDA-approved test, the Food..

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Fam-trastuzumab deruxtecan-nxki is approved by FDA for HER2-low breast cancer

August 2022: For adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH) breast cancer who have received prior chemotherapy in the metastatic setting or experienced a disease recurrence during or within six..

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Fam-trastuzumab deruxtecan-nxki is approved by FDA for breast cancer

April 2022: Adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and have develop..

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