FDA's approval of Sanofi-Aventis' Eloxatin (oxaliplatin) is unlikely to increase the drug's patient base, but the new formulation should consolidate Sanofi-Aventis' position as the largest pharmaceutical firm in Europe and a major player in colorectal cancer treatment.
According to Datamonitor, overall uptake of Eloxatin is unlikely to increase although doctors are likely to switch to the new formulation at the earliest opportunity. As a result, Eloxatin is expected to consolidate its position as a leading drug for the treatment of colorectal cancer.
Eloxatin (oxaliplatin) is a platinum compound that is commonly used for the first and second-line treatment of colorectal cancer in combination with 5-FU and leucovorin. The original formulation, which was marketed in 2002 in the US, was in a sterile, preservative-free lyophilized powder form that had to be reconstituted with sterile water.
The new formulation comes as a preservative-free solution, which does not require reconstitution prior to dilution and administration and is therefore ready to use and of greater convenience.
Given that colorectal cancer is the third most common cancer in terms of incidence and mortality among both men and women, with one million new cases diagnosed annually worldwide, it is clear that patient potential is enormous.
According to the American Cancer Society, colorectal cancer is the second leading cause of cancer-related death in the United States, accounting for 10 per cent to 15 per cent of all cancer deaths. Each year 56,000 people die from colorectal cancer in the United States. In Europe the figure is 94,000.
The new constitution of the drug means an extension of its patent from 2013 to 2015. Having achieved blockbuster status in 2004, the extra two years of patent protection is likely to have significant and positive implications for the drug's overall sales.
Eloxatin was granted its first marketing approval in 1996 for the second-line treatment of metastatic colorectal cancer in France. Subsequent approvals have been granted throughout Europe and the US, within the adjuvant, first-line and second-line treatment settings. The drug has already reached blockbuster status, generating just over $1.5 billion (€1.2 billion) in sales in 2004.
The FDA's approval for Eloxatin's new formulation comes after a recent trial showed a 9 per cent improvement in disease-free survival in stage III patients after four years median follow up.
Sanofi, which also markets Taxotere (docetaxel), an oncologic cytotoxic, is set to become the main player within this sector as potential revenues from the new formulation could push Eloxatin's sales towards the $2 billion mark in a few years' time.
Colorectal cancer is cancer that begins in the cells that line the colon or rectum. When these cancer cells spread away from the colon to distant locations in the body, the cancer is referred to as metastatic. Cancer cells may spread, or metastasise, through the blood or lymphatic system, or directly grow into tissues adjacent to the original cancer.
A diagnosis of colorectal cancer is associated with a stage, which reflects the extent of the cancer and whether it has spread. Patients with colorectal cancer that has spread to distant organs or tissues are said to have advanced, or metastatic, colorectal cancer, also known as stage IV colorectal cancer. Patients with advanced colorectal cancer can now more confidently expect to live twice as long as they could only a few years ago.