EU approves Roche, Novartis cancer drugs

The European Medicines Agency said it was giving a green light for the approval of Roche's Tarceva to treat patients with a genetically distinct type of non-small-cell lung cancer (NSCLC).

It is also recommending Novartis's potential blockbuster drug Afinitor in patients with advanced pancreatic neuroendocrine tumours (NET), the latest boost for the drug in the wake of positive data in breast cancer.

Recommendations for marketing approval by the agency's Committee for Medicinal Products for Human Use (CHMP) are normally endorsed by the European Commission within a couple of months.

Roche and Novartis are the top two global players in oncology.

Roche is seeking to use Tarceva as a first-line monotherapy in patients diagnosed with advanced epidermal growth factor receptor activating mutation positive NSCLC, and is another example of the group's push into personalised healthcare.

Tarceva is already sold for second and third-line treatment, regardless of genetic profile, and had sales last year of 1.3 billion Swiss francs ($1.58 billion).

Novartis's Afinitor is also another example of taking a more targeted approach to treating cancer. The drug targets mTOR, a protein that acts as an important regulator of tumour cell division, blood vessel growth and cell metabolism.

The European agency has recommended Afinitor to treat unresectable or metastatic, well or moderately differentiated neuroendocrine tumours of pancreatic origin in adults with progressive disease.

Afinitor is already approved for treating kidney cancer and the US Food and Drug Administration has already approved Afinitor in this setting, despite concerns about serious side effects.

At 1353 GMT, Roche stock was trading 1 percent firmer, but Novartis shares were down 1.3 percent, while the European pharmaceuticals sector was largely unchanged.

Copyright Reuters, 2011