The US Food and Drug Administration (FDA) has granted priority review to Novartis’ RAD001 (everolimus) on the basis of the drug’s potential to benefit patients suffering from advanced kidney cancer who showed no improvement after the standard treatment. The data collected from a trial shows that RAD001 curbs tumor growth, reducing the risk of disease progression by 70%.Novartis has already applied for marketing authorization for RAD001 with the European Medicines Agency (EMEA) and the Swiss Agency for Therapeutic Products (Swissmedic). EMEA has even accepted the proposed brand name for RAD001, Afinitor®.

Oncothyreon has filed an INDA with the FDA for PX-866, a small molecule phosphatidylinositol-3-kinase (PI-3-kinase) inhibitor for the treatment of advanced cancers. The compound has been shown to have good single agent in vivo antitumor activity and works well in combination with other agents in a number of human tumor models, the company said. Following FDA review, the company plans to initiate a Phase I clinical trial.

Pre-clinical studies conducted by Yale scientists have indicated that the NV-128 compound can induce the death of chemo-resistant ovarian cancer cells by halting the activation of a protein pathway called mTOR. mTOR signals enhance tumor growth in cancerous cells and inhibition of mTOR could shut down many of these survival pathways, including proteins that protect the mitochondria of cancer cells. NV-128, developed by Novogen Limited, holds promise as a more targeted therapy for ovarian cancer because it works differently from traditional therapies that are dependent on enzymes, known as caspases, to trigger cell death.