Novartis's Drug for Lung Cancer Gets FDA Nod

Novertis's drug Zykadia is now approved by the U.S. Food and Drug Administration for use in patients with a certain type of lung cancer.

According to the federal health regulator, Zykadia (ceritinib) is for patients with metastatic ALK-positive non-small cell lung cancer who were previously treated with a drug called crizotinib.

Zykadia belongs to a type of drug called anaplastic lymphoma kinase (ALK) tyrosine kinase, which work by blocking the proteins that help cancer cells develop.

FDA has granted the Novartis drug breakthrough therapy designation. Zykadia received the federal approval four months ahead of the expected date, Reuters reported.

Estimates by National Cancer Institute show that 224,210 Americans will be diagnosed with lung cancer this year. Around 85 percent of all lung cancers belong to the NLCC category. However, only 2 to 5 percent of these patients are AALK positive.

"Today's approval illustrates how a greater understanding of the underlying molecular pathways of a disease can lead to the development of specific therapies aimed at these pathways," said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, according to a news release.

The safety and efficacy of the new drug was tested via a clinical trial on 163 participants with metastatic ALK-positive NSCLC.

All the participants received Zykadia. Researchers found that around 50 percent of the patients had reduction in cancer size. The shrinkage lasted about seven months.

Currently, crizotinib is the only other approved drug in ALK tyrosine kinase class.

"Zykadia represents an important treatment option for ALK+ NSCLC patients who relapse after starting initial therapy with crizotinib," said lead investigator Alice T. Shaw, MD, PhD, Massachusetts General Hospital Cancer Center, Boston, in a statement. "This approval will affect the way we manage and monitor patients with this type of lung cancer, as we will now be able to offer them the opportunity for continued treatment response with a new ALK inhibitor."

Common side effects of the drug include diarrhea, nausea, vomiting, the federal agency said.