EU approval of capecitabine for metastatic colorectal cancer

4 Feb 2008
Many more patients can now benefit from oral chemotherapy that significantly reduces treatment time.

It was announced today that the European Commission has approved the oral chemotherapy capecitabine (Xeloda) for the treatment of metastatic colorectal cancer in combination with any chemotherapy in all lines of treatment with or without Avastin.

This broad approval means that more patients suffering from colorectal cancer that has spread will now be able to take advantage of effective and innovative treatments with proven patient benefits.

Approval was based on the pivotal studies demonstrating two key factors: Firstly that the treatment is more flexible with less hospital time, whilst continuing to deliver the same survival benefits and safety as the previous standard intravenous chemotherapy. And secondly that Avastin in combination with chemotherapy allows patients to live significantly longer without their cancer progressing.

"Colorectal cancer is a devastating disease and treatment options for patients have been limited," said Jim Cassidy, Cancer Research UK Professor of Oncology and Chair of Medical Oncology, Beatson Oncology Centre, at the University of Glasgow, Scotland. "Until now, Xeloda has been available to only a few colorectal cancer patients. But several studies have now shown that almost all patients with colorectal cancer that has spread can benefit from Xeloda at any time and in combination with any chemotherapy treatment. It is a highly effective oral chemotherapy that reduces hospital treatment time by 160 hours compared to the old standard chemotherapy, allowing patients to live as normal a life as possible."

"This approval shows that the EU authorities have endorsed that oral Xeloda can replace intravenous chemotherapy in all colorectal cancer regimens, making cancer treatment regimens easier for patients," Professor Cassidy concluded.

It is estimated that more than 400,000 people in Europe will be diagnosed with metastatic colorectal cancer every year. The previous standard treatment, iv 5-FU was particularly burdensome on patients. Oral Xeloda may offer a better alternative that can be used alone or in combination with oxaliplatin or irinotecan to provide a therapy that is more effective, safe and flexible.

Data submitted to the regulatory authorities that contributed to the broad approval included pivotal studies on XELOX (Xeloda with oxaliplatin) with or without Avastin and supporting studies on XELIRI (Xeloda in combination with irinotecan) with or without Avastin.