Roche said the European Commission has approved its oral chemotherapy Xeloda (capecitabine) for the treatment of metastatic colorectal cancer in combination with any chemotherapy in all lines of treatment with or without Avastin. The new 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 Xeloda tablets providing patients with a more flexible treatment option with less hospital treatment time, whilst continuing to deliver the same survival benefits and safety as the previous standard chemotherapy intravenous (iv) 5-FU. The study also proved 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 Professor 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 iv 5-FU in all colorectal cancer regimens, making cancer treatment regimens easier for patients," Professor Cassidy added.
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. Now oral Xeloda offers a better alternative that can be used alone or in combination with oxaliplatin or irinotecan to provide a therapy that is highly 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.
NO16966 is a large, international phase III trial which recruited 2,034 patients. It was originally planned to compare Xelox vs Folfox as first-line treatment in metastatic colorectal cancer. After release of the pivotal Avastin data in colorectal cancer in 2003, the protocol was amended to investigate using a 2 by 2 factorial design: Folfox/Xelox + placebo vs Folfox/Xelox + Avastin.
The primary objective was to answer whether the Xelox regimen is non-inferior to Folfox, and whether the addition of Avastin to chemotherapy improved progression-free survival compared to chemotherapy alone. The secondary endpoints included overall survival, overall response rates, time to, and duration of, response and safety profile.
The chemotherapy combination Xelox is as effective in terms of progression-free survival- a measure of the time patients live without their disease progressing - as Folfox. The addition of Avastin to chemotherapy (Folfox and Xelox) significantly improved progression-free survival compared to chemotherapy alone.
The NO16967 trial is a large, international phase III trial which randomised 627 patients from 15 countries world-wide who had previously received irinotecan-containing combination chemotherapy and whose disease had returned or continued to progress. The primary objective was to answer whether the Xelox regimen (Xeloda plus oxaliplatin) is as effective as Folfox-4 (i.v. bolus and infusional 5-FU/leucovorin plus oxaliplatin) in terms of progression-free survival. The secondary outcomes to be reviewed included overall survival, overall response rates, and safety profile. The results showed that the chemotherapy combination Xelox is as effective in terms of progression-free survival as the chemotherapy combination Folfox.
Xeloda is licensed in more than 100 countries worldwide including the EU, USA, Japan, Australia and Canada and has been shown to be an effective, safe, and convenient oral chemotherapy in treating over 1.5 million patients to date.