Monday, August 6, 2012

USFDA and EMA approves Afinitor (Everolimus) for Hormone Receptor +ve and HER2-ve breast cancer patients based on breakthrough benefit

The US FDA has approved everolimus (Afinitor®) for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole.

The approval was based on the results of a double-blind, placebo-controlled Phase III study (BOLERO-2) that included 724 postmenopausal women with advanced HR+ breast cancer with recurrence or progression following prior therapy with letrozole or anastrozole.   

Everolimus was Associated with a Median PFS of 11.0 months compared to 4.1 as per Independent Central Radiology Review

Patients treated with everolimus plus exemestane had a median progression-free survival (PFS) of 7.8 months, compared to 3.2 months for those treated with exemestane alone (hazard ratio 0.45; 95% CI 0.38 to 0.54; p<0.0001), according to local investigator assessmentAs per an Independent central radiology review showed the results to be 11.0 months compared to 4.1 months, respectively (hazard ratio 0.38; 95% CI 0.31 to 0.48; p<0.0001).

 The most common adverse reactions (incidence ≥30%) included stomatitis, infections, rash, fatigue, diarrhoea and decreased appetite. The most common grade 3-4 adverse reactions (incidence ≥2%) included stomatitis, infections, hyperglycaemia, fatigue, dyspnoea, pneumonitis and diarrhoea.

About Everoliums / Afinitor
AFINITOR is a prescription medicine used to treat:
  • Advanced hormone receptor-positive, HER2-negative breast cancer, along with the medicine exemestane, in postmenopausal women who have already received certain other medicines for their cancer
  • Adults with a type of pancreatic cancer known as pancreatic neuroendocrine tumor (PNET) that has progressed and can not be treated with surgery. It is not known if AFINITOR is safe and effective in people with carcinoid tumors
  • Adults with advanced kidney cancer (renal cell carcinoma or RCC) when certain other medicines have not worked
  • Adults with a kidney tumor called angiomyolipoma, seen with a genetic condition called tuberous sclerosis complex (TSC), when their kidney tumor does not require surgery right away
    • The effectiveness of AFINITOR in treating angiomyolipoma of the kidney is based on a study of patients treated over an average of 8.3 months. More information is needed to understand the long-term effects of treatment with AFINITOR
  • Adults and children 3 years and older with a brain tumor called subependymal giant cell astrocytoma (SEGA) seen with a genetic condition called tuberous sclerosis complex (TSC) who cannot have surgery for their tumor
    • It is not known if AFINITOR is safe and effective in children under 3 years of age with SEGA