Innovation Pharmaceuticals Inc (IPIX)

[slcimmuno]

Was a Speedy Approval for Opdivo
More Background

http://www.fiercebiotech.com/story/bristol-myers-bags-record-fast-approval-its-cancer-blockbuster/2015-03-04

EXCERPT

Opdivo's speedy lung cancer approval is based on Phase II data in which it significantly increased rates of survival among patients with NSCLC. In January, Bristol-Myers divulged that, in a Phase III study pitting Opdivo against the standard cancer-killer docetaxel, the drug demonstrated such superior overall survival compared with the control arm that it hit its primary endpoint ahead of schedule, leading the trial's data monitoring committee recommend the study be terminated early.

The FDA's rolling review for Opdivo was by far the fastest for any treatment in recent memory and again affirms FDA oncology chief Richard Pazdur's penchant for rapidly approving cancer therapies that could improve the standard of care for some of the most dire patients.

"The FDA worked proactively with the company to facilitate the early submission and review of this important clinical trial when results first became available in late December 2014," Pazdur said in a statement. "This approval will provide patients and health care providers knowledge of the survival advantage associated with Opdivo and will help guide patient care and future lung cancer trials."

Opdivo's second trip through the FDA "is the fastest approval I've seen in my 15-year career," Evercore ISI analyst Mark Schoenebaum noted soon after the news hit.