Novartis has suffered a setback on getting expanded approvals for Afinitor after the drug failed in a late-stage trial as a treatment for advanced liver cancer.

The Swiss major has presented Phase III data which showed that Afinitor (everolimus) did not extend overall survival compared to placebo in patients with locally advanced or metastatic hepatocellular carcinoma  after progression on or intolerance to Bayer's Nexavar (sorafenib). Novartis has therefore decided not proceed with regulatory filings for the drug which is already approved for kidney, breast and pancreatic cancer.

Novartis is not giving up on Afinitor for other indications, however, and it is in Phase III in other diseases, including gastrointestinal and lung neuroendocrine tumors, HER2 positive breast cancer, lymphoma and tuberous sclerosis complex. Results of these trials are expected during 2014 and 2015.

Afinitor is already a big earner for Novartis and second-quarter sales soared 76% to $308 million.