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FDA grants priority review to six hematology/oncology agents

Issue: October 25, 2017

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The FDA has granted priority review to six drugs under investigation for a variety of hematologic and oncologic indications.

These include:

• acalabrutinib (ACP-196, AstraZeneca) — a highly selective, potent Bruton tyrosine kinase inhibitor — for the treatment of patients with previously treated mantle cell lymphoma;
• alectinib (Alecensa, Genentech/Roche) — a kinase inhibitor — for the first-line treatment of patients with ALK-positive, locally advanced or metastatic non-small cell lung cancer as detected by an FDA-approved test;
• arsenic trioxide injection (Trisenox, Teva Pharmaceutical Industries Ltd.) for use in combination with all-trans retinoic acid for induction of remission and consolidation in patients with newly diagnosed low- or intermediate-risk acute promyelocytic leukemia that includes t(15;17) translocation or PML/RAR-alpha gene expression;
• bosutinib (Bosulif, Pfizer), an oral tyrosine kinase inhibitor, for the treatment of patients with newly diagnosed, chronic phase Philadelphia chromosome-positive chronic myeloid leukemia;
• brentuximab vedotin (Adcetris, Seattle Genetics) — an antibody-drug conjugate directed to CD30 — for the treatment of cutaneous T-cell lymphoma; and
• emicizumab (ACE910; Genentech, Roche) — an investigational bispecific monoclonal antibody designed to bring together factors IXa and X — for the treatment of adults, adolescents and children with hemophilia A with factor VIII inhibitors.

Visit Healio.com/HemOnc and search “FDA News” to read more on these FDA actions and others.