Positive EU opinion for pancreatic cancer drug Tarceva
pharmafile | January 3, 2007 | News story | Sales and Marketing |
Roche and Genentech's Tarceva has received a positive EU opinion for the treatment of metastatic pancreatic cancer and approval is expected imminently.
It follows a re-examination of trial data by the European Committee for Medicinal Products for Human Use (CHMP) for this form of cancer treatment.
Tarceva (erlotinib) has already been approved in the US and in a further 15 countries worldwide for first-line treatment of patients with locally advanced, inoperable or metastatic pancreatic cancer, in combination with Lilly's Gemzar (gemcitabine) chemotherapy.
Roche says Tarceva is the first drug in over a decade to have shown a significant survival rate in patients with this devastating and aggressive disease, which kills more people than any other form of tumour within the first year of diagnosis.
The disease is the 10th most frequently occurring cancer in Europe. In 2002, more than 78,000 new cases were diagnosed in the EU alone, with a death rate of approximately 82,000 people a year.
Furthermore, the cancer is difficult to treat as it is often resistant to chemotherapy and radiotherapy and spreads quickly to other parts of the body.
Phase III results showed that Tarceva plus Gemzar in patients with advanced pancreatic cancer resulted in a significantly longer survival – 23% – compared to Gemzar alone, with nearly a quarter of patients receiving the combination still alive one year later, compared to 19% only on Gemzar.
Analysts Datamonitor believe, however, that Tarceva may struggle to achieve the same commercial success in Europe as it has in the US, because of its high cost.
At more than $2,000 a month, analysts say European cash-strapped healthcare systems are unlikely to justify the addition of up to $12,000 in treatment costs for a five-week increase in expected survival.
"As such, Roche/OSI Pharmaceuticals will need to work hard to effectively communicate the impact and value of Tarceva in pancreatic cancer so as to ensure a successful and continued market uptake within the EU," a spokesman said.
Tarceva is currently in a wide range of trials to treat a number of cancers, including other solid tumours such as ovarian, bronchioloalveolar, colorectal, head and neck and gloma (brain).
