Roche, Genentech and OSI Pharmaceuticals’ oncology agent, Tarceva (erlotinib), has won approval from the Canadian regulator, Health Canada, for the treatment of patients with locally advanced or metastatic non-small cell lung cancer who have failed on first- or second-line chemotherapy, opening up another potentially large market for the drug.
Approval was based on clinical data that have been published in this week’s edition of The New England Journal of Medicine, in which patients receiving Tarceva had a 30% reduction in the risk of death, versus placebo. The median survival was 6.7 months for patients who received Tarceva and 4.7 months for patients who received placebo – a 43% improvement. In addition, 31% of Tarceva-treated patients were alive at one year versus 22% in the placebo arm.
Tarceva is also approved in the US and Switzerland [[22/11/04d]], [[22/03/05a]], and has received the backing of the European advisory board, the CHMP [[27/06/05b]], with an approval decision expected within the coming months. The firms also recently filed the drug with the US Food and Drug Administration as a possible treatment for pancreatic cancer [[03/05/05e]], [[07/07/05d]]. The product brought in $48 million dollars in second quarter sales for Genentech – up 47% [[12/07/05a]].
There are more than 1.2 million cases worldwide of lung and bronchial cancer each year, with NSCLC accounting for almost 80% of all the cases.
- Meanwhile, Genentech is planning to offer $2 billion of five- 10- and 30-year new senior notes and says it will use the net proceeds of around $585 million to reduce or repay certain lease arrangements, including a lease relating to a manufacturing facility in California. The company also intends to use the monies to fund the upgrade, start-up and validation costs at its recently acquired biologics manufacturing facility in Oceanside, California. Remaining funds will be used for general corporate purposes.