Issue: July 10, 2017
July 11, 2017
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Several agents receive fast track designation
Issue: July 10, 2017
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The FDA granted fast track designation to five agents designed to treat hematologic or oncologic conditions.
These include:
- the first-in-class EZH2 inhibitor tazemetostat (Epizyme) for the treatment of patients with relapsed or refractory follicular lymphoma, regardless of whether they harbor EZH2 mutations;
- pelareorep (Reolysin, Oncolytics Biotech) — an immuno-oncology viral agent designed to induce selective tumor lysis and promote an inflamed tumor phenotype through innate and adaptive immune responses — for the treatment of metastatic breast cancer;
- SB-525 (Sangamo Therapeutics) — a complementary DNA gene therapy that uses an adeno-associated virus with a clotting Factor VIII gene construct — for the treatment of hemophilia;
- CB-839 (Calithera Biosciences) — a first-in-class, oral, selective, potent glutaminase inhibitor — for use in combination with everolimus (Afinitor, Novartis) for the treatment of patients with metastatic renal cell carcinoma who received at least two prior lines of therapy; and
- OXi4503 (combretastatin A1-diphosphate, Mateon Therapeutics) — a dual-mechanism vascular disrupting agent — for the treatment of acute myeloid leukemia.
For more information about these agents or other regulatory actions, visit Healio.com/HemOnc and search “FDA news.”