In the News: April 2016

On April 11, 2016, the FDA approved venetoclax (Venclexta), the first-in-class BCL-2 inhibitor, for the treatment of patients with chronic lymphocytic leukemia (CLL) and 17p deletion who received ≥1 previous therapies.
In this response, Roy and colleagues explain the model’s rationale, noting that its overall objective was to provide a framework for future use.
Inflectra is approved for several indications, similar to its originator, including severe plaque psoriasis, and active ankylosing spondylitis or psoriatic arthritis.
On March 30, 2016, the US Food and Drug Administration (FDA) approved defibrotide sodium (Defitelio; Jazz Pharmaceuticals) for the treatment of children and adult patients with hepatic veno-occlusive disease plus kidney or lung abnormalities after hematopoietic stem-cell transplantation. This is the first drug to be approved by the FDA for patients with severe hepatic veno-occlusive disease.
On March 11, 2016, the US Food and Drug Administration (FDA) approved an expanded indication for crizotinib (Xalkori; Pfizer) for the treatment of patients with metastatic non−small-cell lung cancer (NSCLC) that harbors the ROS-1 genetic mutation. Crizotinib is the first and only FDA-approved treatment for this patient population; the drug blocks ROS-1 protein activity in tumors, with the potential to prevent NSCLC tumors from spreading.
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.
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.
Today, the US Food and Drug Administration (FDA) granted accelerated approval for an oral medication to treat patients with advanced non—small-cell lung cancer (NSCLC).
The US Food and Drug Administration (FDA) today approved Cotellic (cobimetinib) to be used in combination with vemurafenib to treat advanced melanoma that has spread to other parts of the body or can't be removed by surgery, and that has a certain type of abnormal gene.
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