Novartis is celebrating the news that regulators in the USA have given the thumbs-up to Afinitor for advanced kidney cancer.

Afinitor (everolimus) has been approved by the US Food and Drug Administration (FDA) for patients with advanced renal cell carcinoma after failure with two other treatments – Pfizer’s Sutent (sunitinib) or Bayer’s Nexavar (sorafenib). The approval is based on data that showed Afinitor, when compared with placebo, more than doubled the time without tumour growth or death in patients with advanced kidney cancer (4.9 versus 1.9 months) and reduced the risk of disease progression or death by 67%.

Novartis noted that additional data has shown that after 10 months of treatment with everolimus, approximately 25% of patients still had no tumour growth. The firm added that prior to Afinitor, which is a once-daily, oral treatment that inhibits the mTOR protein, “no other therapy has been studied in a Phase III trial in this patient population where there is an important unmet medical need”.

In 2008, the FDA granted priority review status to Afinitor, previously known as RAD001, and Novartis has filed regulatory submissions in the European Union, Switzerland and Japan. David Epstein, head of Novartis Oncology, noted that “we continue to study Afinitor in kidney cancer, and through a broad clinical program to explore its potential in many other tumour types”.

Novartis believes that Afinitor could be a blockbuster and it is also in development for lymphoma, breast, gastric, lung and other cancers, as well as tuberous sclerosis.

Intercell’s JE vaccine approved
Novartis has also been boosted by the news that partner Intercell has received approval from the FDA for Ixiaro, a vaccine against Japanese encephalitis.

JE, a mosquito-borne infection, affects about 30,000 to 50,000 people each year in Asia, resulting in 10,000 to 15,000 deaths. It is rarely seen in the USA, but Karen Midthun, acting director of the FDA's Center for Biologics Evaluation and Research, noted that Ixiaro “offers protection for individuals who travel to or live in areas where outbreaks are known to occur,"

Ixiaro is the only vaccine approved for JE, which starts as a flu-like illness but can cause high fever, neck stiffness, brain damage, coma, or even death. The approval had pushed up shares in Intercell, an Austrian-based biotechnology company, by 10.5% this morning (10.38 UK time) to 23.15 euros.