ODAC gives thumbs-up to imetelstat for MDS, upholding the value of transfusion independence

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The FDA Oncologic Drugs Advisory Committee voted 12:2 to recommend approval of the drug imetelstat for a myelodysplastic syndrome indication.

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Paul Goldberg
Editor & Publisher
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Zymeworks Inc., a clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, announced that FDA has cleared the investigational new drug application for ZW171, a novel 2+1 T-cell targeting bispecific antibody for mesothelin-expressing cancers.
FDA granted accelerated approval to repotrectinib (Augtyro) for adult and pediatric patients 12 years and older with solid tumors that have a neurotrophic tyrosine receptor kinase gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and that have progressed following treatment or have no satisfactory alternative therapy.
Paul Goldberg
Editor & Publisher