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Home » FDA ACCEPTS OSI PHARMACEUTICALS' SNDA FOR TARCEVA
FDA ACCEPTS OSI PHARMACEUTICALS' SNDA FOR TARCEVA
July 11, 2005
The FDA has accepted for filing and review OSI's supplemental new drug application (sNDA) for use of Tarceva plus gemcitabine chemotherapy for the treatment of advanced pancreatic cancer in patients who have not received previous treatment.
Tarceva (erlotinib) is the only EGFR therapy shown to provide a statistically significant survival benefit in patients treated in first-line locally advanced or metastatic pancreatic cancer in combination with gemcitabine. In addition, Tarceva has been granted priority review classification by the FDA. Based on this priority review status, the FDA has six months from receipt of the sNDA data, or until November 2 to take action on the sNDA filing.
KEYWORDS Drug Pipeline Alert
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