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The CHMP has declared a positive opinion for Afinitor® (everolimus) tablets, combined with exemestane, for hormone receptor-positive (HR+), HER2/neu-negative (HER2-) advanced breast cancer, in certain postmenopausal women.
The subclass of postmenopausal women in whom Afinitor® has been given a positive opinion are those without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.
“Afinitor represents the first major innovation in HR+/HER2- advanced breast cancer since aromatase inhibitors were introduced more than 15 years ago,” said Hervé Hoppenot, President, Novartis Oncology.
“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 plus Iceland and Norway.
The CHMP opinion was based on pivotal Phase III data from the randomised, double-blind, placebo-controlled, multi-centre 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).
Each year, an estimated 220,000 women globally will be diagnosed with HR+/HER2- advanced breast cancer. Women with advanced breast cancer have a life expectancy of approximately 18-36 months after diagnosis.
Endocrine therapy remains the cornerstone of treatment for these women, but most will eventually develop treatment resistance. Therapeutic resistance has been associated with overactivation of the PI3K/AKT/mTOR pathway.
Afinitor targets the mTOR pathway in cancer cells. mTOR is a protein that acts as an important regulator of tumour cell division, blood vessel growth and cell metabolism.
Afinitor is currently being considered in this patient population for approval by the US Food and Drug Administration, the Swiss Agency for Therapeutic Products (Swissmedic) and by health authorities worldwide. Afinitor is also being studied in HER2-positive breast cancer in two Phase III trials.