With cancer drugs, the first approval is only the beginning. An indication for one type of cancer can become two or three if drugmakers play their cards right--and if the treatments themselves prove their versatility. But the road to broader use for cancer meds is full of potholes. Just witness the news about Novartis' Tasigna and Afinitor and Pfizer's Sutent.
Novartis stopped a new trial of Tasigna, approved to treat a type of blood cancer, after it failed to fight gastrointestinal stromal tumors any better than its predecessor, Gleevec (also sold as Glivec). As Reuters reports, Novartis has been hoping Tasigna would be a solid replacement for the $4 billion Gleevec, which goes off patent in a few years. Analysts said the stopped trial is a $500 million disappointment, because Tasigna could have brought in that half-billion in sales had it proved superior for that type of cancer.
Meanwhile, FDA reviewers are questioning new indications in pancreatic cancer for Novartis' Afinitor and Pfizer's Sutent. The companies want to market these drugs for a rare type of pancreatic tumor, but the FDA is questioning the data submitted to support the indication. In Sutent's case, FDA says Pfizer's move to stop a trial early may have skewed the results, making Sutent appear more effective than it really was. The agency also said the drug didn't show a significant improvement in overall survival.
The FDA also questioned Novartis' data on Afinitor's benefits. The company said it has addressed the FDA's questions by narrowing its proposal for the new indication. Previously, it had asked for approval for other neuroendocrine tumors, too. An FDA advisory panel meets tomorrow to discuss the two drugs.
The good news for Afinitor and Sutent is that this type of pancreatic tumor is rare, and so are the treatments. "Given the lack of other treatment options (Pfizer and Novartis) go into this panel with a stronger likelihood of approval," Morningstar analyst Damien Conover said.