FDA clears Genentech's Tarceva for lung cancer, but limits apply

Biotechnology companies Genentech and OSI Pharmaceuticals have announced that US regulators have approved their drug Tarceva for treating the most common form of lung cancer.

The once-daily pill is designed to target human epidermal growth factor receptors and block them from allowing cancer cell growth.

The FDA decision comes more than two months ahead of the agency's scheduled deadline.

But shares of Genentech and OSI Pharmaceuticals fell on concern over limitations in prescribing the cancer drug Tarceva.

Piper Jaffray analyst Thomas Wei said in a report the package insert for Tarceva contains a surprise that could potentially lower use of the drug. The label describes subgroups of patients analysed according to whether they genetically express the epidermal growth factor receptor, against which Tarceva is directed.

"Its inclusion in the label suggests that the FDA found the analysis important for physicians to consider," Wei said. "If physicians choose to limit their usage to EGFR-positive patients, our estimates for sales in lung cancer, which assume 55 per cent penetration of the relapsed market at peak, may prove aggressive."

Analysts had estimated that Tarceva, one of a new class of targeted therapies offering hope to cancer patients for whom more traditional treatments have failed, could generate annual sales of some US$1.6 billion by 2009 for joint developers OSI and Genentech, as well as Genentech's majority-owner Roche.

The US regulatory approval applies to patients with locally advanced or metastatic non-small cell lung cancer who have failed at least one previous round of chemotherapy.

Lung cancer is the most common form of cancer, accounting for 1.2 million cases a year worldwide, while non-small cell lung cancer accounts for almost 80 per cent of all types of lung cancer.

Colin Goddard, OSI's chief executive, said Tarceva's wholesale price will be $2,026 for a 30-day supply, which is more expensive that Iressa, a targeted lung cancer drug sold by AstraZeneca.

In a pivotal-stage trial, patients receiving Tarceva had a median survival of 6.7 months compared to 4.7 months in patients who received placebo. In addition, 31.2 per cent of patients receiving Tarceva in the study were alive at one year versus 21.5 per cent in the placebo arm.

Side effects included rash and diarrhoea.

Goddard said the companies plan to file early next year for FDA approval of Tarceva as a treatment for pancreatic cancer. The drug is also being studied for a range of other cancers including ovarian and head and neck.