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Eight important FDA actions

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The FDA took action this week on several treatments intended to benefit patients with cancer.

HemOnc Today highlights eight regulatory approvals or designations that may be important to your practice.

• The FDA approved ibrutinib (Imbruvica; Pharmacyclics, Janssen) — a Bruton’s tyrosine kinase inhibitor — as the first therapy specifically intended to treat adults with chronic graft-versus-host disease. Read more.
• The FDA approved CPX-351 (Vyxeos, Jazz Pharmaceuticals) — a liposome-encapsulated combination of daunorubicin and cytarabine — for two types of poor-prognosis acute myeloid leukemia. Read more.
• The FDA granted priority review to alectinib (Alecensa, Genentech/Roche) — a kinase inhibitor — for first-line treatment of ALK-positive, locally advanced or metastatic non-small cell lung cancer. Read more.
• Acalabrutinib (ACP-196, AstraZeneca) — a highly selective, potent Bruton’s tyrosine kinase inhibitor — received priority review for use in patients with previously treated mantle cell lymphoma. Read more.
• The FDA granted breakthrough therapy designation to acalabrutinib for previously treated mantle cell lymphoma. Read more.
• The FDA approved enasidenib (Idhifa; Celgene, Agios) — an oral targeted inhibitor of the IDH2 enzyme — for treatment of adults with relapsed or refractory acute myeloid leukemia with IDH2 mutations. Read more.
• The FDA approved nivolumab (Opdivo, Bristol-Myers Squibb), a PD-1 checkpoint inhibitor, for the treatment of adult and pediatric patients with microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer that progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan. Read more.
• Durvalumab (Imfinzi; AstraZeneca, MedImmune) — a human monoclonal antibody directed against PD-L1 — received breakthrough therapy designation for the treatment of locally advanced, unresectable non-small cell lung cancer. Read more.