Monthly News Roundup - November 2013

Gazyva: First Designated Breakthrough Drug to Receive FDA Approval

The U.S. Food and Drug Administration has approved Gazyva (obinutuzumab) for use in combination with chlorambucil to treat patients with previously untreated chronic lymphocytic leukemia (CLL). CLL is a slow-growing blood and bone marrow disease; according to the National Cancer Institute, 4,580 will die from CLL this year. In clinical studies that compared the use of Gazyva with chlorambucil to chlorambucil alone in participants with previously untreated CLL, the combined treatment lead to a significant improvement in progression free survival: an average of 23 months compared with 11.1 months with chlorambucil alone.

Imbruvica: Breakthrough Therapy FDA-Approved for Mantle Cell Lymphoma

Mantle cell lymphoma (MCL) is a rare and aggressive type of blood cancer - a form of non-Hodgkin lymphoma - and represents about 6 percent of all non-Hodgkin lymphoma cases in the U.S. The U.S. Food and Drug Administration has approved Imbruvica (ibrutinib), a new treatment for patients with this rapidly spreading blood cancer who have received at least one prior therapy. Imbruvica was evaluated in a study of 111 participants. Of those who took the drug daily, 66 percent had their cancer shrink or disappear. Velcade (bortezomib) and Revlimid (lenalidomide) are also approved for MCL treatment.

Janssen’s Olysio Approved to Treat Hepatitis C Virus

The U.S. Food and Drug Administration has approved Olysio (simeprevir) for hepatitis C virus (HCV) genotype 1 infected adults with compensated liver disease, including cirrhosis. Olysio is a once-a-day, 150-milligram oral dose, given for 12 weeks, used in combination with peginterferon and ribavirin (PR). Peginterferon and ribavirin are dosed for 24 or 48 weeks based on prior treatment and history. Olysio plus PR effectiveness is reduced in patients with genotype 1a Q80K - testing is available for this genotype and alternate therapies may be needed.

Valeant’s Luzu Cream Approved for Skin Fungal Infections

The U.S. Food and Drug Administration has approved Luzu (luliconazole) Cream, 1%, for the adult treatment of several skin fungal infections, including athlete's foot in between toes (interdigital tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis), caused by the organisms Trichophyton rubrum and Epidermophyton floccosum. Luzu is applied in a one-week, once-daily treatment regimen for tinea cruris and tinea corporis; treatment for interdigital tinea pedis is approved with a two-week, once-daily treatment. Other topical antifungal products, such as econazole, clotrimazole or ketoconazole often require a 2-4 week treatment period.

BTG’s Varithena Approved for Varicose Vein Treatment

More than 30 million adults in the US have varicose veins, with women twice as likely as men to develop these swollen, gnarled veins. Varicose veins often require treatment for painful symptoms including cramps, throbbing, tingling and swelling. Varithena (polidocanol injectable foam), a sclerosing agent, has been approved for the treatment of incompetent veins and visible varicosities of the great saphenous vein (GSV) system, which runs the length of leg. Varithena is intended for intravenous injection using ultrasound guidance. Treatment is considered minimally invasive and no sedation is required. Other treatments for varicose veins include thermal ablation and surgery.

Posted: November 2013

View comments