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Seven oncology agents receive priority review

Issue: November 25, 2017

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The FDA has granted priority review to seven oncology agents under investigation for the treatment of patients with solid tumors.

These include:

• abemaciclib (Verzenio, Eli Lilly) — a cyclin-dependent kinase 4/6 inhibitor — for the initial treatment of advanced breast cancer;
• afatinib (Gilotrif, Boehringer Ingelheim) — an epidermal growth factor receptor tyrosine kinase inhibitor — for first-line treatment of patients with metastatic non-small cell lung cancer who harbor EGFR mutations in exon 21 (L861Q), G719X or S768I as detected by an FDA-approved test;
• cabozantinib — (Cabometyx, Exelixis), a small molecule inhibitor of the MET, AXL and VEGFR2 tyrosine kinases — for first-line treatment of advanced renal cell carcinoma;
• durvalumab (Imfinzi; AstraZeneca, MedImmune) — a human monoclonal antibody directed against PD-L1 — for the treatment of patients with locally advanced unresectable NSCLC whose disease has not progressed following platinum-based chemoradiation therapy;
• nivolumab (Opdivo, Bristol-Myers Squibb), a PD-1 checkpoint inhibitor, for the treatment of patients with melanoma who are at high risk for disease recurrence following complete surgical resection;
• olaparib (Lynparza; AstraZeneca, Merck) — a PARP inhibitor approved for use in women with BRCA-related ovarian cancer — for the treatment of patients with germline BRCA-mutated, HER-2-negative metastatic breast cancer who have been previously treated with chemotherapy in the neoadjuvant, adjuvant or metastatic settings; and
• pertuzumab (Perjeta, Roche) — designed to target the HER-2 receptor — in combination with trastuzumab (Herceptin, Genentech) and chemotherapy for adjuvant treatment of patients with HER-2-positive early breast cancer.

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