To: Joseph Colombo who wrote (90 ) 3/20/1998 8:29:00 AM From: Anthony Wong Respond to of 643
Here's some good news concerning Gemzar, and also a news release from LLY: March 19, 1998 1:46 PM DOW JONES ONLINE NEWS FDA PANEL BACKS ELI LILLY'S GEMZAR TO TREAT TYPE OF LUNG CANCER By Otesa Middleton, Staff Reporter WASHINGTON -(Dow Jones)- A Food and Drug Administration advisory panel recommended Thursday that Eli Lilly & Co.'s pancreatic cancer drug Gemzar also be approved for nonsmall cell lung cancer, the most prevalent form of the lung disease. The Oncologic Drugs Advisory Panel voted to recommend that Gemzar be used as a first-line treatment for nonsmall cell lung cancer alone and in combination with another chemotherapy agent, cisplatin. The FDA isn't required to follow the lead of its advisory panels but usually does so. Last year, Gemzar had $175 million in sales, and analysts have said the new indication could see the drug garnering annual sales of $500 million by the year 2000. Gemzar was launched in 1996. Later Thursday, the FDA advisory panel recommended approval of Hoffman-LaRoches Inc.'s Xeloda as a third-line treatment of advanced breast cancer Thursday. The committee recommended the chemotherapy drug, which is in capsule form for use in patients who resist chemotherapy treatment with paclitaxel and anthracycline. The drug was ushered through the FDA's process swiftly because there is no available treatment for patients who don't respond to the two drugs. Dr. Alison Martin, an FDA reviewer, said Xeloda shrank patients' tumors by at least 50%. Also, because the drug made it through the accelerated process, Hoffman-LaRoche will have to conduct post-marketing trials, Martin said. Dr. Kim Margolin, a committee member, said she welcomes an oral chemotherapy drug because many patients who have used other treatments can no longer take drugs intravenously because of lack of vein access. Xeloda has been described by Roche as the first orally-available, tumor-activated anticancer drug. The drug is also the first in a new class of anticancer agents called fluoropyrimidine carbamates. According to industry press reports, the drug is similiar to the cancer drug 5-fluorouracil, but doesn't have the same high level of bone marrow supression and hair loss because it works directly on the tumor. Hoffman-LaRoche, the U.S. arm of Swiss drug company Roche Holding AG (ROHHY), said side effects of Xeloda include diarrhea, nausea, and vomiting. Analysts at Parabas Capital have said peak sales of Xeloda will reach roughly $150 million annually. On Friday, the FDA panel will decide whether Bristol-Myers Squibb Co.'s (BMY) widely-used cancer drug Taxol should be recommended for nonsmall cell lung cancer and advanced ovarian cancer. The drug is already approved as a secondary treatment for breast and other ovarian cancers. Once a drug is cleared by the FDA, however, doctors are free to use them for any therapeutic use they see fit. Originally approved in 1992, Taxol generated sales of $813 million last year. Some analysts have indicated that annual sales of the drug could reach $1.5 billion by 2000. The American Cancer Society estimates there will be 171,500 new cases of lung cancer this year. The society expects 29,000 new cases of pancreatic cancer. Copyright (c) 1998 Dow Jones & Company, Inc. All Rights Reserved. News release from LLY:biz.yahoo.com