FDA New Drug and Biologic Approvals -- 2017 Year-in-Review

New Hematology/Oncology Indications

Keytruda (pembrolizumab)

First cancer treatment approved for microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors.

Actemra (tocilizumab)

First drug approved for giant cell arteritis.

Zelboraf (vemurafenib)

First treatment approved for Erdheim-Chester disease with BRAF V600 mutation.

Stivarga (regorafenib)

First drug approved in almost a decade for hepatocellular carcinoma.

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Cite this: Mary L Windle. FDA New Drug and Biologic Approvals -- 2017 Year-in-Review - Medscape - Jan 11, 2018.