FDA Approves New Treatment for Drug-Resistant Lung Cancer

A study of a new investigational compound for advanced anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC), co-authored by Fox Chase medical oncologist Ranee Mehra, MD, has led to FDA approval of this treatment for patients who have progressed on prior therapy.

Among about 5 percent of NSCLC tumors, translocations involving the ALK gene drive oncogenesis by encouraging the overproduction of ALK. Patients with such ALK-rearranged NSCLC are treated with the ALK inhibitor crizotinib. Although initial response rates are good, most patients develop resistance to crizotinib and relapse within a year.

In this study, published in the New England Journal of Medicine in March, the researchers tested patients’ response to ceritinib, a second generation ALK inhibitor, which preclinical studies had indicated was more potent than crizotinib. The trial showed an overall response rate of 58 percent to ceritinib in patients with advanced ALK-rearranged NSCLC, including those with crizotinib-resistant cancers.

Ceritinib, known commercially as Zykadia and produced by Novartis, received approval from the FDA in April, creating more options for patients with advanced NSCLC, whose post-relapse treatment choices have so far been very limited.

Ranee Mehra, MD

Ranee Mehra, MD

Mehra’s co-authors include Alice T. Shaw, MD, PhD, Dong-Wan Kim, MD, PhD, Daniel S.W. Tan, MB, BS, Enriqueta Felip, MD, PhD, Laura Q.M. Chow, MD, D. Ross Camidge, MD, PhD, Johan Vansteenkiste, MD, PhD, Sunil Sharma, MD, Tommaso De Pas, MD, Gregory J. Riely, MD, PhD, Benjamin J. Solomon, MB, BS, PhD, Juergen Wolf, MD, PhD, Michael Thomas, MD, Martin Schuler, MD, Geoffrey Liu, MD, Armando Santoro, MD, Yvonne Y. Lau, PhD, Meredith Goldwasser, ScD, Anthony L. Boral, MD, PhD, and Jeffrey A. Engelman, MD, PhD.