Tarceva is a once-a-day pill that targets the EGFR pathway. It is designed to inhibit the tyrosine kinase activity of the EGFR signaling pathway inside the cancer cell. Tarceva is indicated as a monotherapy for people with locally advanced or metastatic NSCLC whose disease has progressed after one or more courses of chemotherapy. The drug is not intended to be used at the same time as chemotherapy for NSCLC.
Tarceva is also indicated in combination with gemcitabine chemotherapy for the first-line treatment of people with locally advanced pancreatic cancer, pancreatic cancer that cannot be surgically removed, or pancreatic cancer that has spread to distant body organs.
Reportedly, the extension follows OSI’s submission of further data in support of the application. The original Prescription Drug User Fee Act (PDUFA) date was January 18, 2010. The companies now anticipate FDA action on the sNDA by April 18, 2010.
Both companies are now expected to work closely with the FDA during this extended review period.