Web Exclusives

Last November, osimertinib (Tagrisso), a third-generation EGFR tyrosine kinase inhibitor (TKI) that targets EGFR mutations, including T790M, was approved by the US Food and Drug Administration (FDA) for the treatment of patients with metastaticEGFR T790M mutation–positive non–small-cell lung cancer (NSCLC) whose disease progressed during or after EGFR TKI therapy.
On May 18, 2016, the US Food and Drug Administration (FDA) approved atezolizumab (Tecentriq; Genentech) for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or after platinum-containing chemotherapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
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.
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.
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