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Weekly Drug News Round-Up: March 2, 2016

FDA Approves Gilead’s Odefsey for HIV-1 Infection Treatment

Tenofovir alafenamide is a prodrug of tenofovir with high antiviral efficacy and a dose less than one-tenth that of Gilead’s Viread Read More…

This week, the U.S. Food and Drug Administration (FDA) approved Odefsey (emtricitabine, rilpivirine and tenofovir alafenamide), a fixed-dose NNRTI and NRTI complete regimen for the treatment of HIV-1 infection. Odefsey is approved in patients 12 years and older who have no antiretroviral treatment history and HIV-1 RNA levels less than or equal to 100,000 copies per mL. Odefsey can also be used in patients on a stable antiretroviral regimen with HIV-1 RNA less than 50 copies per mL for at least six months, no history of treatment failure, and no known substitutions due to resistance to any Odefsey components.

Pfizer’s Xeljanz XR Once-Daily Approved for Rheumatoid Arthritis

Originally, Xeljanz was approved in 2012 as a 5 mg tablet taken twice a day for RA Read More...

Rheumatoid arthritis (RA) is a chronic, inflammatory autoimmune disease that leads to pain and swelling in the joints, often of the hands, feet and knees. FDA has now approved Pfizer’s Xeljanz XR (tofacitinib citrate) extended-release 11 mg tablets for the once-daily treatment of moderate to severe rheumatoid arthritis (RA) in patients who have had an inadequate response or intolerance to methotrexate (MTX). Xeljanz XR is the first once-daily oral RA drug for adults in the Janus kinase (JAK) inhibitor class.

FDA Approves Afinitor for GI and Lung Neuroendocrine Tumors (NET)

For this new indication, Afinitor, by Novartis, received a priority review designation Read More...

Neuroendocrine tumors are a rare type of cancer that originate in neuroendocrine cells in the body, most often in the gastrointestinal (GI) tract, lungs or pancreas. This past week, FDA approved Afinitor (everolimus) tablets by Novartis for the treatment of adults with progressive, well-differentiated, nonfunctional neuroendocrine tumors (NET) of GI or lung origin that cannot be removed surgically, locally advanced or metastatic. In the pivotal trial (RADIANT-4) Afinitor reduced the risk of tumor progression by 52 percent and increased median progression-free survival (PFS) by 7.1 months. Common side effects included infections, diarrhea, stomatitis, fatigue and hyperglycemia.

Genentech’s Gazyva Wins New Indication Approval for Follicular Lymphoma

Gazyva is also approved for previously untreated chronic lymphocytic leukemia (CLL) Read More...

Gazyva (obinutuzumab) is a CD20-directed cytolytic antibody, an injectable cancer medication. This past week, FDA approved Gazyva plus bendamustine chemotherapy followed by Gazyva alone as a new treatment for follicular lymphoma in those who have failed certain other treatments. Follicular lymphoma is a slow-growing non-Hodgkin’s lymphoma (NHL) and accounts for roughly one in five cases of NHL. In the Phase III GADOLIN study, Gazyva plus bendamustine followed by Gazyva alone demonstrated a 52 percent reduction in progression-free survival (PFS). Common side effects include infusion reactions, low white blood cell counts, nausea, fatigue, cough, and diarrhea.

Essure Contraceptive Device: Concerns Prompt Black Box Warning

Bayer must also conduct a “real world” clinical study to assess risks in women Read More...

Essure is a permanent birth control device that consists of flexible coils that are inserted into the fallopian tubes where scar tissue forms naturally around the coils, creating a barrier to prevent sperm from reaching the egg. Since Essure’s approval in 2002, FDA has received over 10,000 complaints related to the device. Side effects can include pain, abnormal bleeding, and tearing of the uterus or fallopian tubes if the device migrates. In addition to the Black Box Warning, a “patient decision checklist” is a proposed addition to new labeling to adequately inform women of risks and responsibilities related to the device.