The FDA has opened the inside track to Novartis' experimental lung cancer drug, which gained "Breakthrough Therapy" designation that speeds the development and review schedules for new treatments. The Swiss drug giant ($NVS) plans to file for approval the drug, now in mid-stage clinical trials, in early 2014. Since clinical development began in 2011, the program has advanced with lightning speed compared with those that take 10 years or so to trial before submitted for approval.
While there are no guarantees of an FDA approval for Novartis' compound, code-named LDK378, the "breakthrough" tag provides an early nod to the potential of the candidate to improve treatment for patients with metastatic non-small cell lung cancer with anaplastic lymphoma kinase (ALK) mutations. The Novartis compound could offer another option for these patients whose cancer progresses despite treatment with Pfizer's ($PFE) approved drug Xalkori (crizotinib).
The "breakthrough" designation is also important because Novartis' compound and others with the coveted status have a shot to be approved by the FDA without completing all three phases of clinical trials typically required before an approval decision...