FDA Approvals

On March 4, 2016, the US Food and Drug Administration (FDA) approved a new type of coagulation factor IX (recombinant), albumin fusion protein (Idelvion; CSL Behring), for use in children and adults with hemophilia B. Used to replace a naturally occurring clotting factor functionally deficient or defective in these patients, this is the first coagulation factor-albumin fusion protein drug to be approved by the FDA.
Omnigraft (Integra Omnigraft Dermal Regeneration Matrix) has been approved by the FDA to treat patients with diabetes who have certain foot ulcers. The device, which is made of silicone, cow collagen, and shark cartilage, provides an environment for new skin and tissue to regenerate and heal the wound when placed over an ulcer.
Irinotecan liposome injection (Onivyde), in combination with leucovorin and 5-FU, was approved by the FDA in October 2015 as the only treatment option for patients with advanced or metastatic pancreatic cancer that progressed after gemcitabine-based chemotherapy.
Fluad, a trivalent vaccine produced using 3 flu virus strains—2 subtype A and 1 type B—has been approved for the prevention of seasonal influenza in patients aged ≥65 years. The vaccine was approved using the accelerated approval regulatory pathway.
Sugammadex (Bridion) injection has been approved by the US Food and Drug Administration to reverse the effects of neuromuscular-blocking drugs (rocuronium bromide and vecuronium bromide) used during tracheal intubation in adults. This injection may help patients recover from these drugs sooner.
Uridine triacetate (Vistogard) has been approved by the US Food and Drug Administration for emergency treatment of patients who receive an overdose of fluorouracil or capecitabine, or those who develop severe toxicities within 4 days of treatment with either therapy.
The US Food and Drug Administration has approved the oral drug alectinib (Alecensa) for the treatment of patients with metastatic, ALK-positive, non−small-cell lung cancer (NSCLC) who could not tolerate, or whose disease worsened after, receiving therapy with crizotinib (Xalkori).
At the end of November, the FDA approved elotuzumab (Empliciti) for use in combination with lenalidomide and dexamethasone in patients with multiple myeloma who have received 1 to 3 previous medications. Elotuzumab is the second FDA-approved monoclonal antibody for patients with multiple myeloma; the first agent (daratumumab) was approved earlier in the month.
Ixazomib (Ninlaro) has been approved for use in combination with lenalidomide (Revlimid) and dexamethasone for the treatment of patients with multiple myeloma who have received at least 1 previous therapy. This is the first oral proteasome inhibitor to be approved for this patient population.
Daratumumab (Darzalex) received accelerated approval for patients with multiple myeloma who have received ≥3 treatments, according to the FDA. This is the first monoclonal antibody approved for multiple myeloma.
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