Hematology/oncology drugs receive priority review

Issue: October 10, 2020

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The FDA granted priority review designation to several therapies in development for hematology/oncology indications.

They include:

• durvalumab (Imfinzi, AstraZeneca), an anti-PD-L1 agent, for administration in a 4-week, fixed dose regimen for the treatment of patients with non-small cell lung cancer and bladder cancer, providing an alternative treatment schedule to the approved weight-based dosing of 10 mg/kg every 2 weeks if approved;
• melflufen (INN melphalan flufenamide, Oncopeptides AB), a first-in-class peptide-drug conjugate that targets aminopeptidases, in combination with dexamethasone for the treatment of adults with triple-class refractory multiple myeloma;
• oral paclitaxel and encequidar (Athenex) — a novel, highly specific, potent P-glycoprotein pump inhibitor that increases absorption of oral paclitaxel — for the treatment of metastatic breast cancer;
• the anti-PD-1 therapy pembrolizumab (Keytruda, Merck) in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer and tumor PD-L1 expression, defined as a combined positive score of 10 or higher. The agent also received priority review for the second-line treatment of patients with relapsed or refractory classical Hodgkin lymphoma;
• relugolix (Myovant Sciences), a once-daily oral gonadotropin-releasing hormone receptor antagonist, for the treatment of men with advanced prostate cancer;
• tepotinib (MSC2156119, Merck/EMD Serono), an investigational oral MET kinase inhibitor, for patients with metastatic NSCLC who harbor MET exon 14 skipping alterations;
• trilaciclib (G1 Therapeutics/Boehringer Ingelheim) — a cyclin dependent kinase 4/6 inhibitor designed to preserve bone marrow and immune system function during chemotherapy — for treatment of patients with small cell lung cancer who are receiving chemotherapy; and
• umbralisib (TGR1202, TG Therapeutics), an oral dual inhibitor of the PI3 kinase-delta and casein kinase-1 epsilon, for patients with previously treated marginal zone lymphoma who received at least one prior anti-CD20-based regimen.

For more information on these decisions and others, visit Healio.com/HemOnc and search “FDA news.”