• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

Sanofi-Aventis: Taxotere Fighting to Maintain Blockbuster Status

Posted on: Wednesday, 29 March 2006, 12:00 CST

Sanofi-Aventis has extended the patient population available to its blockbuster cancer drug Taxotere having won FDA approval for the drug as a treatment of advanced stomach cancer. However, although the decision marks the first US approval within the disease since 1970, the FDA's positive review is unlikely to add significantly to Taxotere's sales.

Taxotere (docetaxel), was approved by the US regulator in combination with cisplatin and 5-flurouracil (5-FU) as a first-line treatment for metastatic gastric cancer including tumors of the gastro esophageal (GE) junction. With this latest FDA approval, Taxotere is now indicated for six indications within the US for four different tumor types including breast, non-small cell lung cancer and prostate. Within gastric cancer, Taxotere has already gained Japanese approval and looks set to gain European approval following recent recommendation by the CHMP.

Gastric cancer is the fourth most common tumor type and second leading cause of cancer-related death, accounting for 930,000 new cases and 700,000 deaths per year worldwide. Patients are under served, with limited treatment options available leading to poor prognosis. The current standard treatment consisting of epirubicin in combination with cisplatin and 5-FU offers a median overall survival of 8.9 months.

However, with Taxotere demonstrating an overall median of 9.2 months, and thus just a three week survival improvement, the approval is unlikely to bring a dramatic improvement to the treatment of gastric cancer.

Similarly, the approval is unlikely to add significantly to Taxotere's sales. By initially targeting three of the 'big four' tumor types - breast cancer, prostate cancer and lung cancer - Sanofi-Aventis has ensured substantial income for Taxotere, solely due to the high patient potential in these indications.

Sanofi-Aventis is now undertaking an expansion of indications by targeting niche cancers, which have smaller patient potential but high unmet needs. By targeting those tumor types where no standard of care or only ineffective treatment exists, any positive clinical trial data is bound to result in significant uptake of the drug. While unlikely to add significant amounts to Taxotere's total sales, high uptake in niche indications will help the drug maintain its blockbuster status.

Indeed, given that Bristol-Myers Squibb is not undertaking further expansion of indications for Taxol, Taxotere is presented with the opportunity to remain the standard therapy in numerous indications.

Source: Datamonitor

More News in this Category