Express Pharma

CHMP recommends Novartis drug Afinitor for EU approval

0 99

Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Afinitor (everolimus) tablets. This in combination with exemestane, for the treatment of hormone receptor-positive (HR+), HER2/neu-negative (HER2-) advanced breast cancer, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.

Hervé Hoppenot, President, Novartis Oncology said, “Afinitor represents the first major innovation in HR+/HER2- advanced breast cancer since aromatase inhibitors were introduced more than 15 years ago. The Committee’s support of Afinitor brings us one step closer to providing an important new option for women living with this disease.”

The European Commission generally follows the recommendations of the CHMP and usually delivers its final decision within three months of the CHMP recommendation. The decision will be applicable to all 27 European Union member states plu