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The FDA has approved pertuzumab injection (Perjeta) for use in combination with trastuzumab (Herceptin) and docetaxel (Taxotere) for the treatment of patients with HER2-positive metastatic breast cancer who have not yet received anti-HER2 therapy or chemotherapy for metastatic disease. Pertuzumab works by blocking HER2-related processes.



GlaxoSmithKline is changing the label of Zofran (ondansetron), a drug used to suppress chemotherapy- and radiotherapy-induced nausea and vomiting, to remove the 32-mg single IV dose, and to state that no single IV dose of the drug should exceed 16 mg. Preliminary study results suggest that the 32-mg dose may affect the electrical activity of the heart, possibly leading to the development of the potentially fatal heart arrhythmia Torsades de Pointes.



Persons with multiple myeloma who have received at least two prior therapies, including bortezomib (Velcade) and an immunomodulatory therapy, are now eligible for treatment with carfilzomib injection (Kyprolis). The FDA granted accelerated approval; however, it advises that patients be monitored closely and taken off the therapy if heart failure or shortness of breath occur.



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FDA Update



The first genetic test to help determine whether the drug cetuximab (Erbitux) would be effective in certain people with colorectal cancer has received FDA approval. The therascreen KRAS RGQ PCR Kit can provide information about the KRAS gene mutation in persons whose cancer has metastasized; cetuximab has been shown to be ineffective in patients with this mutation.
 (Corrected August 21, 2012)

The FDA has granted premarket approval to the Prostate Health Index (phi), manufactured by Beckman Coulter Inc. The manufacturer describes phi as a simple, noninvasive blood test that is 2.5 times more specific in detecting prostate cancer than measuring prostate-specific antigen (PSA) in men with elevated PSA values (4-10 ng/mL). According to a statement from the manufacturer, the phi test reduced the number of unnecessary prostate biopsies by 31% .



Another option for colonoscopy preparation has reached the market in the form of Prepopik (sodium picosulfate, magnesium oxide, and citric acid). The FDA has approved the colon-cleansing powder, which consists of two packets of powder. Patients must mix the packets with cold water and drink them in two separate doses.
 ONA