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Four hematology/oncology products receive breakthrough therapy designation

Issue: November 25, 2017

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The FDA has granted breakthrough therapy designation to four hematology/oncology agents.

These include:

• brentuximab vedotin (Adcetris, Seattle Genetics) — an antibody-drug conjugate directed to CD30 — in combination with chemotherapy for frontline treatment of advanced classical Hodgkin lymphoma;
• the combination of dabrafenib (Tafinlar, Novartis), a BRAF inhibitor, and trametinib (Mekinist, Novartis), a MEK 1/2 inhibitor, for adjuvant therapy of patients with stage III BRAF V600 mutation-positive melanoma;
• osimertinib (Tagrisso, AstraZeneca) — an irreversible EGFR TKI — for the first-line treatment of patients with metastatic EGFR-positive non-small cell lung cancer; and
• the investigational gene therapy valoctocogene roxaparvovec (BMN 270, BioMarin Pharmaceutical) for the treatment of patients with hemophilia A.

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