FDA unanimously recommends GSK’s kidney cancer treatment
PHILADELPHIA A Food and Drug Administration advisory committee has recommended approval for a new kidney cancer drug.
GlaxoSmithKline announced that the FDA’s Oncologic Drugs Advisory Committee had voted unanimously to recommend approval for Votrient (pazopanib), an investigational pill-based treatment for renal cell carcinoma.
“Kidney cancer is a very serious disease, therefore the committee’s recommendation in support of pazopanib is an important step towards bringing a new, oral treatment option to advanced renal cell cancer patients,” GSK VP oncology research and development Rafael Amado said in a statement. “We look forward to working with the FDA towards the approval of pazopanib.”
The committee based its decision based on a phase 3 trial presented at the American Society of Clinical Oncology’s annual meeting this year. FDA advisory committees’ recommendations don’t guarantee full FDA approval, but are taken into account when the agency decides whether to approve a drug.
CDC launches second annual Get Smart About Antibiotics Week
WASHINGTON Taking antibiotics when not needed threatens both individuals and the public, and government officials have enlisted pharmacists to promote smart use of antibacterial medicines.
The Centers for Disease Control and Prevention has launched its second annual Get Smart About Antibiotics Week, which takes place from Monday, Oct. 5, through Friday, Oct. 9. The CDC said pharmacists around the country have joined the campaign to educate patients on when to use and when not to use antibiotics.
Antibiotics are designed to treat bacterial infections, but many patients use them to treat colds and flus, which result from viral infections, and many physicians feel pressure from patients or parents to prescribe antibiotics, especially during the flu season. Not only will antibiotics not work on these infections, but patients taking them place themselves at risk of contracting bacterial infections resistant to antibiotics.
“We are very pleased to have pharmacists as partners in this important effort,” Get Smart program medical director Lauri Hicks said in a statement. “They are extremely knowledgeable and can make a big difference in public health.”
FDA approves Schering-Plough’s skin cancer treatment
GAITHERSBURG, Md. A Food and Drug Administration advisory committee has recommended approval of a biotech drug to treat skin cancer.
The FDA’s Oncologic Drugs Advisory Committee voted six-to-four Monday to recommend approval for Schering-Plough Corp.’s Pegintron (pegylated interferon alfa-2b) as an adjuvant treatment for stage 3 malignant melanoma. The drug, a long-acting form of the protein interferon alfa-2b is administered weekly by self-injection and already approved as treatment for hepatitis C.
“Treating malignant melanoma remains a challenge given the limited treatment options that are currently available,” University of Pittsburgh School of Medicine professor and Division of Medical Oncology chief John Kirkwood said in a statement. “Today’s positive recommendation of pegylated interferon alfa-2b by the committee represents an important step toward a potential new option in the treatment of stage 3 malignant melanoma, especially as the incidence of the disease continues to increase.”
FDA advisory committees’ recommendations do not mandate approval of a drug, but the agency weighs them when considering whether to grant final approval.