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 belinostat (Beleodaq; Spectrum Pharmaceuticals) for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), a rare and fast-growing type of non-Hodgkin lymphoma (NHL).
The FDA issued an expanded indication for ibrutinib (Imbruvica; Pharmacyclics) for the treatment of patients with CLL who have a deletion in chromosome 17 (17p deletion), which results in poor response to standard CLL therapies.
The FDA approved idelalisib (Zydelig; Gilead Sciences) for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL) to be used in combination with rituximab (Rituxan).
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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  • Rheumatology Practice Management
  • Lynx CME
  • American Health & Drug Benefits
  • Value-Based Cancer Care
  • Value-Based Care in Myeloma
  • Value-Based Care in Neurology