Novartis' Afinitor gets nod for breast cancer use by EU committee

Novartis ($NVS) got what it had hoped for Friday, a thumbs up from the EU's Committee for Medicinal Products for Human Use (CHMP) for a new use for its cancer drug Afinitor. The CHMP recommended it for use in women with advanced breast cancer.

The company points out in a release that the European Commission generally follows the recommendations of the CHMP within 90 days, so the drug could be approved for that purpose by fall. The FDA is also looking at Afinitor for this use.

What is certain is that Novartis' hopes for Afinitor just got a huge boost. It has said Afinitor could bring in an additional $1 billion per year from a new use in breast cancer. But others predict even more. After a study last year showed really positive results for women with advanced breast cancer taking Afinitor, the Bank Vontobel analyst Andrew Weiss bumped his forecast for breast cancer sales to $1.8 billion from $1.5 billion. He set his peak sales at $3.5 billion. It is already marketed as a treatment for kidney and pancreatic cancer.

That study found that the drug more than doubled progression-free survival when added to standard hormonal therapy in post-menopausal women with estrogen-receptor-positive breast cancer. The drug, which targets the mTOR protein in cancer cells, also cut the risk of disease progression 57% compared with Pfizer's ($PFE) Aromasin hormone therapy alone. Most women with metastatic cancer treated with hormonal therapy develop resistance over time, and that resistance has been associated with mTOR, the very protein that Afinitor targets, Novartis has said.

The company said separately it received positive opinion from the committee for the once-daily Seebri Breezhaler to treat patients with chronic obstructive pulmonary disease in the EU.

- here's the CHMP summary
- read Novartis' press release