FDA Drug Approvals
The FDA approved the first anti– programmed death receptor-1 (PD-1) therapy, pembrolizumab (Keytruda; Merck), for patients with unresectable or metastatic melanoma and disease progression after treatment with other melanoma therapy, such as ipilimumab, or, for a patient with BRAF V600 mutation, after BRAF inhibitor therapy.
Bortezomib (Velcade; Millennium/Takeda Oncology), which is already approved by the FDA as an intravenous (IV) or subcutaneous treatment for patients with multiple myeloma, recently received a supplemental new indication for the retreatment of adults with myeloma whose disease had previously responded to bortezomib therapy and had relapsed (ie, progressed) at least 6 months after the last treatment with bortezomib.
The FDA approved technetium Tc 99m tilmanocept (Lymphoseek Injection; Navidea Biopharmaceuticals) for an expanded use for guiding sentinel lymph node (SLN) biopsy in patients with head and neck cancers with squamous-cell carcinoma of the oral cavity.
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