OSI Pharmaceuticals reported FDA clearance of its flagship anticancer drug, Tarceva®, as maintenance therapy for patients with locally advanced or metastatic non-small-cell-lung cancer (NSCLC) that has not progressed after four cycles of platinum-based, first-line chemotherapy. The announcement comes less than a month after OSI and its partner, Roche, confirmed that the EMEA’s Committee for Medicinal Products for Human Use (CHMP) was also in favor of extending approval of Tarceva into the equivalent maintenance NSCLC therapy indication.
The latest FDA approval and European recommendation for approval of the Tarceva NSCLC maintenance therapy indication are based on data from the global Phase III SATURN trial. The study involved 889 patients with advanced disease. Participants whose disease had not progressed after four cycles of standard first-line platinum-based chemotherapy were randomized to receive either Tarceva or placebo.
The results showed overall survival was 23% higher in the Tarceva group compared with the placebo group. Tarceva therapy also improved progression-free survival by 41% and reduced the risk of cancer progression or death by 29%.
FDA clearance of Tarceva for maintenance NSCLC therapy has not been without incidence, however. In December 2009, the agency’s Oncologic Drugs Advisory Committee voted by 12 to one against approval of the maintenance NSCLC therapy indication. The following month FDA extended the review period for the sNDA by 90 days following OSI’s submission of further data in support of the application.
Tarceva has been approved in the EU since September 2005 and in the U.S. since November 2004 for the treatment of patients with locally advanced or metastatic NSCLC with or without EGFR-activating mutations after failure of at least one prior chemotherapy regimen. According to OSI, the drug is now approved for sale in 109 countries for the treatment of advanced NSCLC.
Tarceva is also approved in the U.S. and Europe in combination with gemcitabine for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.
Roche reported global sales of Tarceva reached CHF 1.3 billion in 2009 (about $1.22 billion), up 10% on 2008, and representing 3% of the firm’s overall global sales. In 2009, the drug represented Roche’s eight biggest selling pharmaceutical.
OSI says that its Tarceva-related revenues reached $359 million in 2009, compared with $335 million in 2008. The 2009 figure included Tarceva-related royalties of $146 million from Roche. Royalty revenues in 2009 were based on Tarceva net sales in the rest of the world of approximately $724 million.
The blockbuster status of Tarceva was one of the reasons OSI gave for its board unanimously rejecting Astellas’ recent and unsolicited $52.00 per share, or reportedly about $3.5 billion, cash bid for the company.