Date: 2012-06-24
Type of information: Granting of a Market Authorisation in the EU
Product name: Afinitor®
Compound: everolimus
Therapeutic area:
Action mechanism: Everolimus targets mTOR in cancer cells, a protein that acts as an important regulator of tumor cell division, blood vessel growth and cell metabolism. Resistance to hormonal therapy in breast cancer has been associated with over-activation of the mTOR pathway.
Company: Novartis (Switzerland)
Disease: 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
Latest news: * On June 21, 2012, the CHMP has adopted a positive opinion for Afinitor® (everolimus) tablets, 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. The CHMP opinion was based on pivotal Phase III data from the randomized, double-blind, placebo-controlled, multi-center BOLERO-2 (Breast cancer trials of OraL EveROlimus-2) trial. The study evaluated 724 patients with HR+/HER2- advanced breast cancer and found that treatment with Afinitor® plus exemestane more than doubled median progression-free survival (PFS) to 7.8 months, compared to 3.2 months with exemestane alone (hazard ratio=0.45 [95% Cl: 0.38 to 0.54]; p<0.0001), by local investigator assessment. An additional analysis based on an independent central radiology review showed Afinitor extended median PFS to 11.0 months compared to 4.1 months (hazard ratio=0.38 [95% CI: 0.31 to 0.48]; p<0.0001)[2]. Afinitor® is also being studied in HER2-positive breast cancer in two Phase III trials. * On July 20, 2012, Novartis has announced that the FDA has approved Afinitor® for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+ breast cancer) in combination with exemestane after failure of treatment with letrozole or anastrozole. The approval was also based on the randomized, double-blind, placebo-controlled, multi-center trial called BOLERO-2 (Breast cancer trials of OraL EveROlimus-2), which evaluated 724 postmenopausal women with advanced HR+ breast cancer with recurrence or progression following prior therapy with letrozole or anastrozole. Marking the fifth indication for Afinitor®, this is the first FDA approval for an mTOR inhibitor in the treatment of advanced HR+ breast cancer in the United States. * On July 30, 2012, Novartis has announced that the European Commission has approved Afinitor® tablets for the treatment of hormone receptor-positive (HR+), HER2/neu-negative (HER2-) advanced breast cancer (HR+ advanced breast cancer), in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2012-07-20
UE authorization: 2012-07-30
Favourable opinion UE: 2012-06-21
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
