It seems Novartis AG’s (NVS) breast cancer drug, Afinitor (everolimus), is getting into a habit of delivering positive news. Right after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approval of Afinitor last week for the treatment of subependymal giant cell astrocytomas (SEGA), the drug impressed again this week with positive interim results from a pivotal late-stage trial (BOLERO-2).

BOLERO-2 evaluated Afinitor in combination with exemestane versus placebo plus exemestane in postmenopausal women with estrogen receptor-positive locally-advanced breast cancer, whose disease progressed, despite treatment with the nonsteroidal aromatase inhibitors letrozole or anastrozole.

The trial results demonstrated that patients with advanced breast cancer who were dosed Afinitor in combination with exemestane, experienced significantly extended progression-free survival (PFS), as compared to patients who received placebo plus exemestane. Following these results, the company halted the trial, as the primary endpoint of PFS was already met. Regulatory filings for Afinitor for the said indication are planned by the end of 2011.

Last week, the CHMP of the EMA recommended approval of Afinitor for the treatment of SEGA, a benign brain tumor associated with tuberous sclerosis (TS). The drug now awaits the European Commission’s decision regarding its approval, which is expected within the next three months.

The drug, which is already approved in the US, Switzerland, Brazil, Colombia, Guatemala, the Philippines and South Korea to treat SEGA associated with TS, will be marketed in the European Union (EU) under the trade name Votubia. Novartis has also filed for approval of the drug for the said indication in many other countries.

Currently, Afinitor is marketed in the US and EU for the treatment of advanced renal cell carcinoma (kidney cancer) along with other anti-VEGF therapies like Roche Holding Ltd.’s (RHHBY) Avastin, Pfizer Inc.’s (PFE) Sutent and Onyx Pharmaceuticals’ (ONXX) Nexavar.

Afinitor was also recently approved in the US for the treatment of patients with advanced neuroendocrine tumors (NET) of pancreatic origin in May 2011. The company has filed marketing applications in the EU and Switzerland for the treatment of advanced NET of gastrointestinal, lung or pancreatic origin.

Moreover, Novartis is presently testing Afinitor in late stage trials for many cancer types, like diffuse large B cell lymphoma, tuberous sclerosis complex (TSC), gastric cancer and hepatocellular carcinoma (HCC).

Our Take

Currently, we have a Neutral recommendation on Novartis. The company carries a Zacks #3 Rank (Hold rating) in the short run. Though pleased with Novartis’ wide range of products and its efforts to diversify further, as is evident from the acquisition of eye-care company Alcon, we prefer to remain on the sidelines due to the imminent patent cliff faced by the company.

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