Vyvanse for ADHD in Teenagers
Lisdexamfetamine dimesylate capsules (Vyvanse, Shire) have been approved for the treatment of attention adolescents 13 to 17 years of age. Vyvanse was previously approved for treating ADHD in adults and children 6 to 12 years of age. The new approval was based on results from a randomized study of 314 adolescents.
Vyvanse is a federally controlled substance (CII) because it can be abused or may lead to dependence. It is available in six once-daily dosage strengths of20, 30, 40, 50, 60, and 70 mg.
Sources: FDA and Shire, November 15, 2010
Sprycel for Rare Leukemia
Dasatinib (Sprycel, Bristol-Myers Squibb) has been approved for patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. This slowly progressing blood and bone marrow disease is linked to a genetic abnormality.
An oral kinase inhibitor, dasatinib is believed to block the activity of proteins responsible for the growth of cancer cells so that the bone marrow can start reproducing normal red and white blood cells.
In 2006, the FDA granted accelerated approval for dasatinib to treat adults with CP-CML with disease that was resistant to previous therapy, including imatinib (Gleevec, Novartis). In 2009, formal approval was granted.
Bristol-Myers Squibb has launched My Sprycel Support to help patients learn more about the drug. Patients also have access to a care counselor 24 hours every day.
Source: FDA, October 28, 2010
Afinitor for Rare Brain Cancer
Everolimus (Afinitor, Novartis) is now approved to treat subependymal giant cell astrocytoma, a benign brain tumor that is associated with tuberous sclerosis. Tuberous sclerosis is a rare genetic disorder in which tumors grow in the brain, eyes, lungs, liver, heart, skin, and kidneys. Signs may include learning disabilities, skin abnormalities, seizures, and lung and kidney disease.
Everolimus tablets were first approved in March 2009 to treat kidney cancer patients who were not responding to sunitinib (Sutent, Pfizer) or sorafenib (Nexavar, Bayer). Everolimus is also approved as Zortress (Novartis) for preventing organ rejection after kidney transplantation.
Source: FDA, November 1, 2010
Cymbalta for Chronic Pain
The FDA has approved duloxetine HCl (Cymbalta, Eli Lilly) to treat chronic musculoskeletal pain, including discomfort from osteoarthritis and chronic lower back pain. Duloxetine is also indicated for major depressive disorder, diabetic peripheral neuropathy and fibromyalgia, generalized anxiety disorder, and maintenance treatment of major depression.
The FDA assessed the drug’s efficacy in four randomized clinical trials. At the end of the study period, patients taking duloxetine had a significantly greater pain reduction compared with those taking placebo.
The recommended dose is a 60-mg capsule taken once daily without regard to meals.
Source: FDA, November 4, 2010
Herceptin for Stomach Cancer
The FDA has expanded the indication for trastuzumab (Herceptin, Genentech) to include the initial treatment of HER-2- positive (HER-2+) metastatic cancer of the stomach or gastroesophageal junction in combination with chemotherapy.
Trastuzumab has improved outcomes in women with HER-2+ breast cancer. HER-2 protein is also overexpressed in some stomach cancers. The drug blocks HER-2 and is used to treat early-stage and advanced HER-2+ breast cancer.
The drug was evaluated in the phase 3 ToGA study. Half of the patients received chemotherapy alone, and half received chemotherapy plus trastuzumab. Chemotherapy comprised a fluoropyrimidine (capecitabine [Xeloda, Roche]) or 5-flu- orouracil (5-FU) and cisplatin (Platinol, Bristol-Myers Squibb). Overall survival rates were 13.8 months with chemotherapy plus trastuzumab and 11.1 months with chemotherapy alone.
Sources: Reuters and Genentech, October 20, 2010
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