Tarceva’s PDUFA date extended (NASDAQ:OSIP)

Tarceva – which is the brand name for the generic drug erlotinib – is co-marketed by OSI Pharmaceuticals, Inc. (NASDAQ:OSIP) and Roche Holding AG (NASDAQ:RHHBY). Both companies have already submitted a special type of application – known as the Supplemental new drug application (sNDA) – regarding Tarceva to the United States of America’s Food & Drug Administration. Upon receiving the application, the FDA has given OSI Pharma and Roche Holdings AG a Prescription Drug User Fee Act date (also called Action date or just PDUFA date). This was the date on which the Food & Drug Administration must respond to the companies’ application. According to OSI Pharma, the initial PDUFA date for Tarceva was January 18, 2010. However, on January 15, 2010, the corporation disclosed that the United States of America’s one of the toughest regulators, the Food and Drug Administration, has delayed the PDUFA date by 90 days. This means that the new PDUFA date is April 18, 2010

Why did the FDA extend the PDUFA date? The answer was given by OSI Pharmaceuticals and Genentech, Inc., a wholly owned member of the Roche Group, themselves. This was because the companies provided the FDA with additional information that supported the Supplemental New Drug Application of Tarceva. This supplemental application was given to get the FDA’s approval to use Tarceva as “a first-line maintenance therapy in advanced non-small cell lung cancer (NSCLC)”. Although OSI Pharma had filed a suit against Roche Holding recently, both companies have agreed to work together and in harmony with the FDA during the extended time period.

OSI Pharma and Roche Holding have developed a range of drugs for patients suffering from diabetes, obesity and cancer. Tarceva is one such drug which is used for cancer patients. It is taken once every day. The EGFR pathway is targeted by the drug. According to the companies, Tarceva is “designed to inhibit the tyrosine kinase activity of the EGFR signaling pathway inside the cancer cell, one of the critical growth factors in NSCLC and pancreatic cancer”. This drug is used for patients suffering locally advanced or metastatic NSCLC. These patients are generally those who not only had not benefit from chemotherapy but also “whose disease has progressed after one or more courses of chemotherapy”.

As can be easily understood, Tarceva is an alternative for chemotherapy and must not be used in conjunction with chemotherapy for the treatment of NSCLC.

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