Eloxatin approved in US as first line treatment
pharmafile | January 16, 2004 | News story | |
Sanofi-Synthelabo's Eloxatin has received US approval for use as first line treatment of colorectal cancer in combination with standard treatment 5-fluorouracil and leucovorin (5FU/LV).
The FDA gave the drug priority review in September and approved the new indication on the back of data showing patients lived nearly five months longer compared to patients on standard treatment alone.
The US approval follows an expansion of Eloxatin's licence in Europe where it can now be used as first and second line treatment with 5FU/LV.
The company says global sales for 2003 are expected to be E800 million, and forecast it could reach sales of E1 billion by 2006 thanks to further extensions to its use.
New data supporting Eloxatin use in adjuvant treatment following surgery to increase survival rates will shortly be submitted to the regulators in Europe and the US.
Around one million new cases of colorectal cancer are diagnosed worldwide every year, and is the second biggest cancer killer in the US, accounting for 10 to 15% of all cancer deaths.
In the UK, NICE issued recommendation in May 2003 stating that 5FU, Roche's Xeloda (capacitabine) Bristol-Myers Squibb's Uftoral (tegafur with uracil) should be the first treatment options available for people with advanced colorectal cancer.
Eloxatin currently only has NICE recommendation in conjunction with 5FU to treat bowel cancer that has spread to the liver. The treatment may shrink secondary cancer in the liver so that it can be removed with surgery.
Aventis' Campto (irinotecan) is also licensed in the UK for the advanced disease, but NICE only recommends it for patients who cannot tolerate or who have not responded to 5FU.
Related articles
Xeloda recommended for breast and colorectal cancer
Friday, May 30, 2003
