FDA backs Novartis' Afinitor for advanced breast cancer

23 July 2012

There was good news for Swiss drug major Novartis (NOVN: VX) on Friday, when the US Food and Drug Administration approved the firm’s already marketed Afinitor (everolimus) for an additional indication, for use in combination with Aromasin (exemestane) to treat certain postmenopausal women with advanced hormone-receptor positive, HER2-negative breast cancer.

The drug combination is intended for use in women with recurrence or progression of their cancer after treatment with Femara (letrozole) or Arimidex (anastrozole). Breast cancer is the second leading cause of cancer-related death among women. This year an estimated 226,870 women will be diagnosed with breast cancer, and 39,510 will die from the disease. Last month, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion for Afinitor in the HR+/HER2-negative population. Additional regulatory submissions are being reviewed by health authorities worldwide

$1 billion-plus sales forecast

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK



Companies featured in this story

More ones to watch >


Today's issue

Company Spotlight





More Features in Pharmaceutical