Novartis says that its investigational oncology agent everolimus has been granted a fast-track review in the USA.
The Swiss drugmaker notes that the drug, which is also known as RAD001 and will be marketed as Afinitor, has been granted priority review by the US Food and Drug Administration, based on the drug’s potential to become the first therapy to demonstrate significant benefit in patients with advanced kidney cancer after failure of standard treatment. Fast-track status is granted to therapies that could potentially fill a currently unmet medical need and accelerates the standard review timing from ten to six months.
Novartis has also filed marketing authorisation applications for RAD001 with the European Medicines Agency and the Swiss Agency for Therapeutic Products. The submissions are based on data from the RECORD-1 trial presented in May at the American Society of Clinical Oncology meeting which show that after failure of standard treatment in patients with advanced kidney cancer, RAD001 more than doubled time without tumour growth and reduced the risk of disease progression by 70%.
Alessandro Riva, global head of development at Novartis Oncology, said that “currently, patients with advanced kidney cancer who have experienced treatment failure with standard therapies have limited options.” He added that “the priority review designation for RAD001 brings us one step closer to offering these patients a promising new therapy”.
Everolimus is a once-daily, oral therapy that inhibits the mTOR protein, which plays a key role in regulating tumour cell division and the growth of blood vessels in cancer cells. Novartis believes that the compound also has the potential to benefit patients with a variety of cancers, including neuroendocrine, breast, gastric and lung.
