The US Food and Drug Administration will fast track Novartis’ investigational compound LDK378 for the treatment of a rare type of lung cancer.
Novartis said the treatment for anaplastic lymphoma kinase positive (ALK+) metastatic non-small cell lung cancer (NSCLC) has recieved ‘breakthrough therapy’ designation, as there are a limited treatment options available for patients with the disease.
Results of a Phase I study showed that 80% of participants with ALK+ NSCLC, who had progressed during treatment with, or were intolerant to Pfizer’s Xalkori (crizotinib), responded to LDK378.
Breakthrough therapy designation is intended to expedite the review of drugs that treat serious or life-threatening conditions if the therapy has demonstrated substantial improvement over an available therapy on at least one clinically significant endpoint.
Novartis Oncology Development and Medical Affairs global head Alessandro Riva commented on the news; "LDK378 is a strong example of our research approach, which focuses on identifying the underlying cause of disease pathways."
"This Breakthrough Therapy designation will allow us to collaborate more closely with the FDA and potentially to expedite the availability of an important new treatment option for patients with ALK+ NSCLC."
Novartis has initiated two Phase II clinical trials to further evaluate the efficacy and safety of the compound, and Phase III trials are planned later this year.
The first regulatory filing is anticipated by early 2014.
Image: The three main subtypes of NSCLC are adenocarcinoma, squamous-cell lung carcinoma and large-cell lung carcinoma. Photo: Courtesy of Freedigitalphotos.net.