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Biotech / Medical : Pharma News Only (pfe,mrk,wla, sgp, ahp, bmy, lly) -- Ignore unavailable to you. Want to Upgrade?

To: Mike McFarland who wrote (696)	8/26/1998 8:12:00 PM
From: Anthony Wong	Respond to of 1722

Lilly's Gemzar Drug Wins FDA Approval for New Use (Update2) Bloomberg News August 26, 1998, 5:53 p.m. ET Lilly's Gemzar Drug Wins FDA Approval for New Use (Update2) (Adds analyst comment.) Washington, Aug. 26 (Bloomberg) -- Eli Lilly & Co. won clearance to market its already approved Gemzar cancer drug for a new use in treating late stage, non-small-cell lung cancer, according to the U.S. Food and Drug Administration. Gemzar, also called gemcitabine, has been approved by the FDA since 1996 for the treatment of pancreatic cancer. Today's action clears the drug for first-line use in patients diagnosed with advanced forms of the non-small-cell lung cancer and in patients who have seen their lung cancer spread, said FDA spokesman Brad Stone. The drug is given by injection in combination with another widely used cancer drug called cisplatin. Wider clearance for the anti-cancer drug should help Lilly to spur on already-strong sales for the drug. ''So far Gemzar has been a textbook example of how to launch a cancer drug. You start with a very quick approval and then as rapidly as possible you try to move onto the larger indications,'' said Alex Zisson, an analyst with Hambrecht & Quist. ''I think it has surprised a lot of people.'' Shares in Indianapolis, Indiana-based Lilly rose 2 3/4 to close at 77 1/16. Officials from Lilly confirmed that the FDA had approved the new use for the drug and said the company plans to make an announcement soon detailing the new use and providing full prescribing information for Gemzar. The drug had sales of some $175 million in 1997 and accounted for about 2 percent of Lilly's drug sector sales last year. Zisson said he expects the drug to have worldwide sales of $500 million in 2000. In a cancer market where many of the most widely used drugs are generic, those sales would make Gemzar ''one of the top five ever'' in the history of cancer drugs, he said. Off-Label Indications Gemzar is likely to already be used frequently by cancer doctors to treat the late stage lung cancer because cancer drugs are often approved for very narrow uses, then prescribed more widely by doctors for a broader range of so-called off-label indications. Still, agency approval for the additional uses helps to secure market share and increase the odds that a treatment will be reimbursed by insurance companies. The FDA approval is in line with the recommendations of an independent panel of experts which reviewed the drug this spring and agreed with data presented by Lilly showing patients who received Gemzar with another drug survived slightly longer -- by about a month and a half -- than did patients who only received the traditional cancer treatment. While the addition to life expectancy is small, it is significant because past treatments of advanced lung cancer have generally been aimed only at being palliative, that is, to better the quality of life and ease pain for terminally ill patients while they are dying. A different study presented at the panel hearing showed Gemzar to be very potent taken by itself, and to trigger fewer side-effects and milder forms of side-effects such as nausea, vomiting and hair loss than a standard combination of two other drugs. Less Toxicity ''I am not aware of any active single agent. . . that has less toxicity than gemcitabine,'' said Lilly researcher Larry Einhorn, who summarized the studies Lilly and others have done of the drug at the advisory panel. Low toxicity could make the drug an important option for weaker or older patients, who have very advanced lung cancers but are not strong enough to cope with the side effects of other therapies. Patients in trials have had trouble adjusting to the initial dosages of the drug and sometimes required hospitalization. The drug also boosted the frequency of neurological problems when it was taken in combination with other cancer drugs. With more than 178,000 new cases in the U.S. last year, lung cancer is still the leading cause of cancer deaths among men and women, according to the American Cancer Society. It leads to more deaths than the next three causes combined. Gemzar works by blocking the process of DNA replication, which in tumors has gone awry. By mimicking a natural building block involved in replication, the drug essentially gums up the process and kills cells which are multiplying. That makes it an effective cancer killer because cancer cells divide more rapidly than normal human cells. --Kristin Reed in Washington (202) 624-1820 /mfr