FDA approves expanded use of Tarceva
MELVILLE, N.Y. The Food and Drug Administration has approved a drug made by Genentech and OSI Pharmaceuticals for a new use in lung cancer patients, OSI said Friday.
The agency approved Tarceva (erlotinib) as a maintenance therapy for advanced non-small cell lung cancer. The drug already has approval for treating advanced-stage pancreatic cancer when combined with Eli Lilly’s chemotherapy drug Gemzar (gemcitabine).
“We are delighted that lung cancer patients and their physicians will have the option of beginning Tarceva therapy in the first-line maintenance setting,” OSI CEO Colin Goddard said.
Schnucks’ O’Brien to serve on Department of Agriculture advisory committee
ST. LOUIS An executive from Schnuck Markets will serve on an advisory committee of the Department of Agriculture, Schnucks said this week.
Agriculture secretary Tom Vilsack announced that Schnucks VP produce and floral Mike O’Brien would be one of 25 people appointed to a two-year term on the USDA’s Fruit and Vegetable Industry Advisory Committee. O’Brien is also vice chairman of the Produce Marketing Association.
“I am honred to represent Schnuck Markets and the retail produce industry as a member of this committee,” O’Brien said. “I am looking forward to the opportunity to contribute and to make a difference for families across the nation.”
The committee, originally chartered in 2001, advises the secretary of agriculture on industry issues related to fruits and vegetables.
Gilead commences phase 3 trial for single-tablet HIV treatment
FOSTER CITY, Calif. Gilead Sciences has started a late-stage clinical trial of an investigational 4-in-1 treatment for HIV, the drug maker said.
Gilead announced the initiation of a phase 3 trial of its “Quad” HIV drug, a single-tablet treatment that combines elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate. The study will compare the Quad regimen with the standard of care among adults with HIV-1 who have not taken antiretroviral treatments. The company is also investigating cobicistat as a standalone boosting agent for antiretroviral drugs.
“We are pleased to announce that the Quad phase 3 clinical program is underway,” Gilead EVP research and development and chief scientific officer Norbert Bischofberger said. “Efficacy and safety results from the phase 2 study suggest that the Quad may represent an important new option for patients with HIV.”