Roche, Novartis cancer meds win EMA nod

Roche and Novartis both got a boost from European authorities, who are recommending new uses for their targeted cancer drugs. Roche got the nod from European Medicines Agency to market Tarceva for patients with a particular genetic strain of non-small cell lung cancer, while Novartis' Afinitor won backing for use in patients with advanced pancreatic neuroendocrine tumors.

Both new indications will need a final OK from the European Commission, but as Reuters points out, the EC typically follows through on these recommendations within a couple of months.

Tarceva already is a big seller for Roche, with $1.58 billion in 2010 revenues, but the new use promises to broaden its marketing appeal further. The new indication would cover Tarceva as a first-line treatment for NSCLC that has tested positive for a genetic mutation affecting the advanced epidermal growth factor receptor. It's already approved as a second- and third-line treatment for lung cancer with or without the mutation.

Afinitor, on the other hand, is still a sub-$1 billion drug, but Novartis ($NVS) hopes that building up new indications for the drug will eventually push it into blockbuster territory. As Reuters notes, the drug targets a protein that regulates cell division and metabolism, as well as blood-vessel growth. The new indication would allow Afinitor to be marketed for NET tumors that are inoperable or have metastasized. It's already approved for kidney disesase, and recent data have raised hopes that it could win a nod for use in breast cancer. Novartis plans to file for that indication by year's end.

- read the Reuters news
- get more from InPharm

Suggested Articles

Monday, Bernstein analysts echoed what many were probably thinking about Novo Nordisk’s Rybselsus price: “Finally we can stop talking about it.”

Low interest rates and strong stock valuations are two top reasons why U.S. drugmakers are on the move for deals.

Despite a 45% premium offered to Allergan investors through the AbbVie buyout, one investor is suing to block the deal.