The Food and Drug Administration announced approval today for Iressa, a new drug that shrinks tumors in about 10 percent of patients whose lung cancer has progressed despite two prior rounds of standard chemotherapy. Iressa, taken daily in pill form, is the first of a new class of drugs that works by targeting and blocking key growth signals in cancer cells.
Physician: Ronald Natale, M.D., the Principal Investigator on the clinical trial at Cedars-Sinai Medical Center, Acting Medical Director at Cedars-Sinai Comprehensive Cancer Center and National Program Director for Lung Cancer for Salick Health Care, Inc., is available for media interviews. A patient who participated in the study at the Cedars-Sinai Comprehensive Cancer Center and testified before the FDA's Oncologic Drug Advisory Committee is also willing to be interviewed.
Susan Nelson of Perris, California is a School Teacher. A non-smoker, Susan was first diagnosed with a slow-growing lung cancer called bronchoalveolar carcinoma in 1989. Her treatment began with surgery to remove a portion of her right lung and, after her cancer recurred in 1994, she was told that her only option was a heart and lung transplant. Instead, Susan decided not to pursue that treatment option, but by August 2001, the cancer had returned, forming a large mass in each lung. At that point, she enrolled in a clinical trial testing the effectiveness of Iressa and her condition has improved considerably.
The FDA granted approval for Iressa as a treatment of last resort for patients who had failed two or more types of chemotherapy - despite findings that treatment with a combination of Iressa and chemotherapy failed to improve survival for newly diagnosed lung cancer patients. Because Iressa is a drug that targets specific protein molecules expressed on cancer cells, it does not have the side effects typical of treatment with chemotherapy.
Non-small-cell lung cancer is the most common type of lung cancer, a disease that kills about 155,000 Americans each year. Typically, non-small-cell lung cancer is treated with surgery followed by chemotherapy and/or radiation. But because lung cancer is usually diagnosed in its advanced stages, these treatments rarely bring about a cure, with side effects often outweighing any benefits.
The Cedars-Sinai Comprehensive Cancer Center is managed by a subsidiary of Salick Health Care, Inc. Salick Health Care, Inc. is an independently operated subsidiary of AstraZeneca.
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