Roche’s Xeloda widens licence
pharmafile | April 1, 2010 | News story | Sales and Marketing | Cancer, Roche, Xeloda, colorectal cancer
Roche’s oral chemotherapy drug Xeloda has been approved in Europe in combination with intravenous oxaliplatin for the treatment of patients after they have surgery for early colon cancer.
The mixture of Xeloda (capecitabine) and oxaliplatin (Sanofi-Aventis’ off-patent Eloxatin) is known as Xelox and demonstrated significant benefits over chemotherapy alone.
Roche had been eyeing the label extension after results last year from the NO16968 study showed patients taking Xelox immediately after surgery lived disease-free for longer compared to those on chemotherapy regimen 5-fluorouracil/leucovorin (5-FU/LV).
Xeloda works by activating the cancer-killing agent 5-FU directly inside the cancer cells. It can currently be used alone or in combination for colorectal, stomach and breast cancer – and patients require fewer hospital visits as Xeloda is in pill form.
“The approval of XELOX is great news for patients, who now have the added benefits and convenience of oral Xeloda in combination therapy for this disease, which is potentially curable if diagnosed and treated promptly,” said Roche pharma division chief operating officer Pascal Soriot.
Colorectal cancer is the second most common cause of cancer death in Europe and the third most commonly-reported cancer in the world.
Roche says it expects label extensions for the Xelox combination in other countries following the decision by the European Commission.
One of the lead investigators, Professor Hans-Joachim Schmoll of Halle’s Martin Luther University Clinic for Internal Medicine IV, said: “Having a range of treatment options means more patients are given the chance to live without their disease returning, potentially enabling them to be cured.”
The NO16968 trial is a randomised, phase III study taking in more than 1,800 patients in 29 countries, and showed Xelox offered superior disease-free survival at three, four and five years.
In addition to adjuvant colon cancer, Xeloda is currently approved in metastatic colorectal cancer, advanced gastric cancer and metastatic breast cancer.
In February a global study using Roche’s own Avastin (bevacizumab) in combination with Xeloda or fluorouracil and cisplatin chemotherapy failed to show that it could help patients with stomach cancer live longer.
The phase III trial did not meet its primary endpoint of extending overall survival in patients compared to the same chemotherapy plus placebo.
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