Issue: October 25, 2017
October 24, 2017
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FDA grants breakthrough therapy designation to several oncology agents
Issue: October 25, 2017
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Four hematology/oncology drugs have received breakthrough therapy designation from the FDA.
These include:
- acalabrutinib (ACP-196, AstraZeneca) — a highly-selective, potent Bruton tyrosine kinase inhibitor — for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy;
- DS-8201 (Daiichi Sankyo) — an investigational HER-2-targeting antibody-drug conjugate — for the treatment of HER-2-positive locally advanced or metastatic breast cancer that progressed after treatment with other HER-2-targeting agents;
- mogamulizumab (Poteligeo, Kyowa Hakko Kirin), a humanized monoclonal antibody directed against CC chemokine receptor 4, often expressed on leukemic cells of cutaneous T-cell lymphoma and other hematologic malignancies. The investigational agent is intended to treat adults with mycosis fungoides and Sézary syndrome — the most common cutaneous T-cell lymphoma subtypes — who received at least one prior systemic therapy; and
- venetoclax (Venclexta; AbbVie, Roche) — a first-in-class BCL2-specific oral inhibitor — in combination with cytarabine for elderly patients with treatment-naive acute myeloid leukemia who are ineligible for intensive chemotherapy.
Visit Healio.com/HemOnc and search “FDA News” to read more on these FDA actions and others.