Taxotere approved for stomach cancer in US
pharmafile | March 28, 2006 | News story | Research and Development |Â Â Â
Sanofi-Aventis has won US approval to market its drug Taxotere as a treatment for stomach cancer, and says it is the first advance in treatment in over a decade.
US regulator the FDA assessed the drug through its fast-track procedure, granting approval for use in patients with advanced stomach (gastric) cancer, including cancer of the gastro oesophageal junction, who have not received prior chemotherapy for advanced disease.
Data filed by the company showed the drug cut the risk of death by 23% when added to conventional chemotherapy, suggesting Taxotere could significantly prolong lives.
Stomach cancer is the fourth most common type of cancer worldwide with nearly one million new patients every year, with Europe accounting for around 143,000 of these cases. It is also the second most common cause of cancer death worldwide, causing more than 700,000 deaths annually.
Most patients are not diagnosed until the disease is advanced, and have an expected two-year survival of only 11.5%.
"For many years, patients with gastric cancer had limited options for the treatment of their disease," said Jaffer Ajani, professor of GI medical oncology at the University of Texas and principal investigator of the TAX 325 study.
"With the approval of this Taxotere-based regimen in this cancer, a new standard of treatment is now available for advanced gastric cancer patients."
Europe's regulator, the EMEA is also reviewing the drug, with a decision expected later this year.
Patients in the TAX 325 trial were treated with a Taxotere-based chemotherapy regimen (Taxotere plus cisplatin and 5-fluorouracil, TCF) experienced a significant 23% reduction in the risk of death compared to patients who received a current standard treatment of cisplatin and 5-fluorouracil (CF), (median follow-up: 23 months).
The primary study endpoint was time to tumour progression, which was significantly improved with Taxotere-based therapy (5.6 months) compared to standard treatment (3.7 months), with a 32 % reduction in the risk of progression.
The drug is already in use to treat a wide range of cancers, including breast cancer non-small cell lung cancer and prostate cancer.
Taxotere sales rose 15% in 2005 to E1.6 billion ($1.93 billion), making it Sanofi-Aventis' third biggest selling drug and one of the most successful cancer treatments globally.
