a new drug progresses to fast FDA review

[Lani]

mTor is a downstream pathway in her2 + breast cancer and has been stuidied in breast cancer as well:





Novartis Cancer Drug Wins U.S. Priority Review


An investigational drug from Swiss drugmaker Novartis AG has been granted priority review in the United States as a treatment for advanced kidney cancer.

Novartis said on Tuesday that RAD001 or everolimus, which it plans to sell under the brand name Afinitor, had been accepted for fast review given its potential to benefit patients who fail to respond to standard therapy.

U.S. Food and Drug Administration priority review status accelerates the standard review timing from 10 to six months.

Clinical trial results released earlier this year showed 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%.

The new drug works by blocking the protein mTOR and disrupting the growth, division and metabolism of cancer cells.

The once-a-day pill is also being tested in other cancers including lymphoma and neuroendocrine tumours.

[Rich66]

What does "fast review" mean in terms of timeline for availability? Does this just mean fast review for kidney cancer applications?

[Lani]

once it is approved for use for one indication it can be given off-label for others. That does not mean insurance will necessarily pay for it, but it will be obtainable.

I just read a new article demonstrating that the presence of a certain biomarker can predict efficacy of such an mTor inhibitor.