Swiss drugmaker Novartis AG (NVS: Quote) Friday said the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended Afinitor (everolimus) tablets, in combination with exemestane, for the treatment of advanced breast cancer.
Separately, the company said it received positive opinion from the committee for once-daily Seebri Breezhaler to treat patients with chronic obstructive pulmonary disease in the EU.
The positive opinion for Afinitor was adopted for the treatment of hormone receptor-positive or HR+, HER2/neu-negative or HER2-, advanced breast cancer, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.
Around 220,000 women globally are diagnosed with HR+/HER2- advanced breast cancer every year and have a life expectancy of 18-36 months after diagnosis.
Endocrine therapy is the cornerstone of treatment for these women, but there is tendency to develop treatment resistance due to overactivation of the PI3K/AKT/mTOR pathway.
mTOR is a protein that acts as an important regulator of tumor cell division, blood vessel growth and cell metabolism. Afinitor targets the mTOR pathway in cancer cells.
Afinitor is currently being considered in this patient population for approval by the US Food and Drug Administration and the Swiss Agency for Therapeutic Products (Swissmedic). It is also being studied in HER2-positive breast cancer in two Phase III trials.
The opinion of the Committee for Medicinal Products for Human Use or CHMP 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 or PFS to 7.8 months, compared to 3.2 months with exemestane alone, by local investigator assessment.
An additional analysis based on an independent central radiology review showed that Afinitor extended median PFS to 11.0 months compared to 4.1 months.
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."
Novartis said separately that the CHMP has adopted a positive opinion for Seebri Breezhaler (glycopyrronium/NVA237) 44 mcg delivered dose (50 mcg glycopyrronium per capsule), as a once-daily inhaled maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease or COPD.
According to the drugmaker, COPD patients in Phase III GLOW trials experienced improved lung function, reduced shortness of breath, reduced exacerbations, and improved quality of life.
Worldwide submissions and reviews of Seebri Breezhaler (glycopyrronium bromide/NVA237) are ongoing. The US filing for Seebri Breezhaler is expected in 2014.
The European Commission normally follows the recommendations of the CHMP. Its final decision is usually delivered within three months of the CHMP recommendation. The decision will be applicable to all 27 European Union member states as well as Iceland and Norway.
The stock is currently up 0.4 percent in Zurich at 52.70 Swiss francs on a volume of 1.29 million shares.
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by RTT Staff Writer
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