Novartis AG (NOVN) won U.S. approval of its treatment for patients with advanced non-small cell lung cancer.
The drug, ceritinib, gained marketing clearance about four months ahead of the expected decision date because it has the potential to offer substantial improvement over existing therapies, the Food and Drug Administration said today in a statement. Ceritinib, to be marketed by Basel, Switzerland-based Novartis as Zykadia, blocks proteins that promote the development of cancer cells, the agency said.
Lung cancer is the leading cause of cancer-related deaths in the U.S., the FDA said. An estimated 224,210 new cases will be diagnosed this year and more than 159,000 Americans will die from the disease, according to the National Cancer Institute. Zykadia is approved for a small number of patients who have a certain gene mutation.
“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, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “It also demonstrates the FDA’s commitment to working cooperatively with companies to expedite a drug’s development, review and approval, reflecting the promise of the breakthrough therapy designation program.”
Zykadia is the fourth drug to receive approval under the FDA’s breakthrough therapy designation reserved for medicines that show early promise to provide a substantial improvement over existing treatments. The status directs the agency to work closely with the drugmaker to bring the product to market faster than other therapies.
The drug may generate $423 million in sales in 2018, according to the average estimate of seven analysts compiled by Bloomberg. Non-small cell lung cancer accounts for about 85 percent of all lung cancer cases, though just two percent to seven percent of patients have a mutation of the ALK gene Zykadia targets, the FDA said.
Zykadia’s approval is based on the medicine’s ability to shrink tumors and Novartis must prove it benefits patients to keep the drug on the market. Those treated with Zykadia must have previously tried New York-based Pfizer Inc.’s Xalkori.
Common side effects include diarrhea, nausea and vomiting.
“The approval of Zykadia less than three and a half years after the first patient entered our clinical trial exemplifies what is possible with a highly focused approach to drug development and strong collaboration,” Alessandro Riva, global head of oncology development and medical affairs at Novartis, said in a statement.
To contact the editors responsible for this story: Reg Gale at firstname.lastname@example.org Andrew Pollack, Angela Zimm