The Food and Drug Administration (FDA) will take an additional three months to review Wyeth's kidney cancer drug Torisel -- the first of five new medications the company plans to introduce this year.The FDA needs more time to investigate data on tumor growth in patients taking Torisel. If all goes well, the drug will be one of only three to effectively hold off incurable kidney cancer. The other two drugs are Pfizer's Sutent and Bayer AG's Nexavar.
Robert Ruffolo, president of Wyeth Research, says he is encouraged by the review process so far. And he is optimistic about launching the product in late 2007.
Studies show Torisel, which will cost patients about $30,000 per year, prolonged survival by 50 percent in those faring poorly with kidney cancer. The sickest kidney-cancer patients were essentially kept alive for 10.9 months, compared with 7.3 months with interferon drugs. Torisel also postponed tumor growth for 5.5 months. This is 77 percent longer than with interferon.
Sutent and Nexavar, both on the market since last year, also slow tumor growth. All three kidney-cancer medicines are of the variety that block the growth of cancer cells -- different from standard chemotherapy which kills tumors and harms nearby tissues too.
Wyeth is relatively new to the oncology market. And soon, the company hopes to launch three more cancer drugs. One, called CMC-544, treats non-Hodgkin's lymphoma. Another, SKI-606, is for chronic myelogenous leukemia. And the third, HKI-272, is for breast cancer.
About 51,000 Americans will be diagnosed with kidney cancer this year.
