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Tarceva label to include new warnings
Friday, May 08 2009 | Comments
What's This?
The Food and Drug Administration said new warnings would be added to the label of Genentech Inc. and OSI Pharmaceuticals Inc.'s cancer drug, Tarceva (erlotinib).Tarceva's label will now include warnings about reports of gastrointestinal perforation and bullous, blistering and exfoliative skin conditions, as well as a warning about reports of corneal ulcers and perforations. Some of the skin reactions are suggestive of other disorders, such as Stevens-Johnson syndrome or toxic epidermal necrolysis, the agency noted. Patients have died in some of the reported cases.
The companies sent a letter about the warnings to physicians and other health care professionals in April, but the FDA made the letter public on its Web site on Friday.
Tarceva monotherapy is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. Tarceva in combination with gemcitabine hydrochloride is indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.
In March, OSI Pharmaceuticals submitted a supplemental New Drug Application to the FDA for the use of Tarceva as a first-line maintenance therapy for individuals with advanced NSCLC whose disease has not progressed after first-line treatment with platinum-based chemotherapy.
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