PHARMACY

FDA approved Novartis’ kidney cancer treatment

BY Alaric DeArment

ROCKVILLE, Md. The Food and Drug Administration has approved a new drug for treating advanced kidney cancer, the agency said Monday.

The FDA approved Novartis’s Afinitor (everolimus) tablets, for treating patients with advanced kidney cancer, including renal cell cancer, whose disease has progressed after treatment with other therapies.

“Afinitor provides an option for patients with advanced renal cell cancer after failure of treatment with the cancer therapies sunitinib or sorafenib,” FDA Center for Drug Evaluation and Research Division of Drug Oncology Products director Robert Justice said in a statement. “Targeted cancer therapies like Afinitor have increased the number of months patients can live without the tumor progressing.”

Sunitinib and sorafenib are the chemical names of Pfizer’s Sutent and Bayer’s Nexavar, respectively. They belong to the same class of drugs as Afinitor, kinase inhibitors, which prevent cell communication and stop tumor growth.

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FDA approves fast-track designation for Hodgkin lymphoma treatment

BY Alaric DeArment

BOTHELL, Wash. An investigational drug for treating Hodgkin lymphoma has received fast-track designation from the Food and Drug Administration, the maker of the drug has announced.

Seattle Genetics, based in the Seattle suburb of Bothell, Wash., said it received the designation for SGN-35, for which it hopes to soon start a phase 2 study.

“Receiving fast-track designation is another important component of our regulatory strategy for SGN-35 and a key step for this program,” Seattle Genetics president and CEO Clay Siegall said. “With our pivotal trial underway, we expect data in 2011.”

That year, Siegall said, the company hopes to file for regulatory approval, possibly launching the drug in 2012. So far, the drug has received orphan drug designation in the United States and Europe for Hodgkin lymphoma and anaplastic large cell lymphoma.

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GSK submits study results for HPV, cervical cancer vaccination

BY Alaric DeArment

PHILADELPHIA British drug maker GlaxoSmithKline has submitted data from a phase 3 efficacy study on a vaccine for human papillomavirus and cervical cancer to the Food and Drug Administration, the company announced Monday.

The drug, Cervarix (human papillomavirus vaccine [Types 16, 18] recombinant, adjuvanted, adsorbed), is designed to prevent HPV types 16 and 18. The study, called HPV-008, enrolled more than 18,600 girls and women aged 15 to 25 from 14 countries in North America, Latin America, Europe and the Asia-Pacific region. Cervarix already has approval in more than 90 countries, including the member countries of the European Union, Mexico, Australia, Singapore and the Philippines.

“We are pleased to have reached this significant milestone for Cervarix,” GSK VP and director North American vaccine development Barbara Howe said in a statement. “The data submitted to the FDA reaffirm our confidence in the vaccine’s safety and efficacy profile.”

Merck & Co. already has FDA approval for its vaccine, Gardasil (human papillomavirus quadrivalent [Types 6, 11, 16, 18]).

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