Roche says that the European authorities have given a positive opinion to the company’s anti-cancer agent, Xeloda (capecitabine), to be used as an adjuvant treatment, or post-surgery, treatment for colon cancer. Full marketing approval in this new indication is expected to follow within the next few months.
The Swiss company notes that adjuvant chemotherapy is one of the most common treatment approaches for colon cancer where chemotherapy is given in order to destroy any cancerous cells remaining in the body after the tumour has been surgically removed. It points to recent clinical trial data that showed Xeloda to be at least as effective as the intravenous chemotherapy commonly used to treat patients after surgery. However, Xeloda was associated with a more favourable toxicity profile and, as an oral therapy, is more convenient as patients can take it at home.
Final approval in this new indication could significantly expand the market for Xeloda, which brought in sales of some 534 million Swiss francs in 2004 – up 7% [[02/02/05a]].
- Meanwhile, a new 500mg tablet form of the company’s HIV medicine, Invirase (saquinavir), which Roche says will simplify dosing by reducing patients’ daily pill burden, has also won EU backing.