Swiss drug giant Novartis has filed its once-daily cancer pill Glivec/Gleevec (imatinib mesylate) with regulators on both sides of the Atlantic.
The company is seeking permission from the US Food and Drug Administration and the European Medicines Agency to market the drug for a rare form of skin cancer - dermatofibrosarcoma protuberans - and three different blood disorders. “These filings underscore how cancers of different origin and location can share common pathways that respond to the same targeted treatment,” Novartis said in a statement.
Sales of Gleevec, which is a first-line treatment for Philadelphia chromosome-positive chronic myelogenous leukaemia and is also cleared for a rare type stomach cancer, jumped 32% to $590 million in the fourth quarter of last year, after having raked in $1.58 billion in the first nine months of 2005, and so the drug obviously represents a key player in Novartis’ near-term growth.
Since it first hit shelves in 2002 the agent was widely considered to be a ‘breakthrough’ therapy in the battle against cancer and, although these latest indications thankfully affect just a handful of patients, a further regulatory nod would add further support to the continued development of targeted cancer therapies.
"Thanks to the success of targeted therapies like Gleevec, these filings speak to the fundamental shift that we are seeing in the approach to cancer treatments," said Diane Young, Vice President and global head of Clinical Development at Novartis Oncology. "One day, cancer may no longer be classified by site, or even by single genes or proteins, but instead by the way in which the cancer is expressed. This could potentially give rise to more targeted treatment options such as Gleevec."