Novartis (NVS) recently announced positive results on Afinitor, from a phase III trial, BOLERO-3. The study is evaluating Novartis’ Afinitor plus Roche’s (RHHBY) Herceptin and vinorelbine for the treatment of women suffering from HER2 positive (HER2+) advanced breast cancer.
It was observed in the trial (n= 569) that Afinitor plus Herceptin and vinorelbine significantly extended progression-free survival (PFS) after prior therapy vis-à-vis placebo plus Herceptin and vinorelbine.
Novartis will present detailed results at the upcoming annual meeting of the American Society of Clinical Oncology (ASCO).
Novartis estimates that approximately 140,000 women are suffering from HER2 positive advanced breast cancer across the world.
Hence, the successful development and commercialization of Afinitor for the above-mentioned indication will further boost the sales potential of the drug. Afinitor generated sales of $797 million in 2013, up 85% year over year.
We remind investors that Afinitor is already approved in the US and EU (trade name: Votubia) for the treatment of advanced renal cell carcinoma following vascular endothelial growth factor-targeted therapy along with other indications.
In 2012, Afinitor received approval from both European Medicines Agency (EMA) and US Food and Drug Administration (FDA) for the treatment of HR+/HER2- advanced breast cancer in combination with Pfizer’s (PFE) Aromasin, in postmenopausal women whose disease has returned or progressed even after undergoing treatment with a non-steroidal aromatase inhibitor.
We note that Afinitor is an important part of Novartis’ portfolio and are pleased with the company’s efforts to expand the label.
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