OSI Pharmaceuticals, Inc. (OSIP) and Genentech, Inc., now wholly owned by Swiss pharma giant Roche, said their experimental drug , Tarceva, extended overall survival in patients with advanced non-small cell lung cancer or NSCLC, when given directly after initial chemotherapy. The new data may be vital in rendering further support for the pending label expansion of Tarceva, which in turn may resurrect sales for the drug, upon approval. OSIP's top line is largely tied to Tarceva.
The latest data is derived from a pivotal phase 3 study dubbed "Saturn" and is much-awaited by the investor community, as it will support regulatory submissions made in the U.S. And Europe in March. OSIP and Roche - the company's international collaborator for the drug -- are seeking approval for additional use of Tarceva as a first-line maintenance treatment for patients with advanced NSCLC. FDA will decide on the drug on or about January 18, 2010.
The U.S. and European regulatory submissions in March were based on positive data from the Saturn study that showed Tarceva improved progression-free survival by 41% when given as a first-line maintenance treatment to patients with advanced NSCLC, compared to placebo or dummy pill.
Tarceva is already approved as mono-therapy for the treatment of locally advanced or metastatic NSCLC among patients who fail at least one prior chemotherapy regimen. It is also approved, in combination with Eli Lilly's Gemzar for treating advanced pancreatic cancer.
The new data arrives at a time when analysts have been concerned about slowing growth of the Tarceva, which is a key driver for OSIP. The drug represented $83.9 million or 89.5% of the company's overall first-quarter sales of $93.7 million. Tarceva revenues for OSIP grew less than 2% in the first quarter from $82.4 million in the year-ago period and a label expansion may help regrowth in the sales of the drug.
Treating patients immediately following first-line chemotherapy, instead of waiting for the cancer to grow or spread before giving additional treatment represents a new approach in advanced NSCLC, the companies said in a press release Monday.
"This study has now not only confirmed that immediate treatment with Tarceva after initial chemotherapy delayed the progression of disease, but also importantly helped patients in the study live longer," said Professor Federico Cappuzzo, M.D., Istituto Clinico Humanitas IRCCS, Milan and the principal investigator of the study.
Biotech stocks are high risk/reward investments, and largely event-driven. Although the new data looks positive, there is still a long winding path to Tarceva approval, until January of next year.
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