FDA Approves Genentech Lung Cancer Treatment Tarceva
FDA on Thursday approved Tarceva, manufactured by Genentech, as a second- or third-round treatment for advanced non-small cell lung cancer, the New York Times reports. FDA approved Tarceva almost two months before its late January deadline, "making it one of the fastest drug approvals ever," according to the Times (Pollack, New York Times, 11/19). Tarceva, taken once daily, is part of a new class of medications that target the epidermal growth factor responsible for tumor growth (Gellene, Los Angeles Times, 11/19).
In clinical trials, Tarceva prolonged the lives of lung cancer patients by a median of 6.7 months, compared with 4.7 months for patients who took a placebo. Tarceva will compete with Iressa, a rival medication manufactured by AstraZeneca that recently received FDA approval. Iressa, part of the same class of medications as Tarceva, shrank lung cancer tumors in clinical trials but did not prolong patient lives (New York Times, 11/19). Tarceva next week will become available in pharmacies nationwide at a monthly cost of about $2,026 (Los Angeles Times, 11/19). OSI Pharmaceuticals, which developed Tarceva and licensed the rights to Genentech, will help market the medication in the United States. Roche, which owns a majority of Genentech, will market Tarceva abroad, with approval in Europe expected in mid-2005 (New York Times, 11/19).
Sales of Tarceva could reach $260 million next year and $400 million in 2006, when Medicare likely will begin to cover oral medications, according to Deutsche Bank Securities analyst Jennifer Chao (Los Angeles Times, 11/19). Some analysts have estimated that worldwide sales of Tarceva could reach as high as $1 billion annually (Marshall, Long Island Newsday, 11/19). Clinical trials indicate that Tarceva can prolong the lives of pancreatic cancer patients and could serve as an effective treatment for ovarian, head and neck cancers, but Genentech has not decided whether to seek expanded FDA approval for the medication (Tansey, San Francisco Chronicle, 11/19).