EMD Serono wins approval for drug to treat rare form of skin cancer

Gary Zieziula is president and managing director of EMD Serono in Rockland. Jonathan Wiggs/The Boston Globe

Federal regulators Thursday approved a drug to treat Merkel cell carcinoma, a rare and aggressive form of skin cancer, boosting efforts by Rockland-based biotech EMD Serono to expand its franchise in treatments that target specific types of cancer molecules.

The drug, called Bavencio, was approved for patients at least 12 years old, including those who have not yet received chemotherapy.

Bavencio will be EMD Serono’s first cancer drug launch. But the company, a US arm of German drug maker Merck KGaA, has 19 other cancer drug research programs in different stages of development, said Luciano Rossetti, Merck’s global head of research and development.

“We believe this is the beginning,” Rossetti said in an interview. “We have a pipeline that we hope will result in multiple [cancer drug] approvals, starting this year.”

Rossetti said he was celebrating the Bavencio approval Thursday afternoon by drinking champagne with scientists in Billerica who had worked on the program.

Bavencio won accelerated approval by the Food and Drug Administration because there isn’t an existing treatment for the disease. About 1,600 people are diagnosed with Merkel cell carcinoma in the United States each year.

The drug was developed in EMD Serono’s research labs in Massachusetts and in affiliated labs in Europe. The company, a US arm of German drug maker Merck KGaA, last year spent $12 million to expand its research center in Billerica. In January, it licensed four cancer drug research programs from Boston’s lVertex Pharmaceuticals Inc.

Like other immuno-oncology drugs, Bavencio works by stimulating immune systems to attack cancer cells, targeting the interaction of cellular “pathways” that shut down the immune system.

“The scientific community continues to make advances targeting the body’s immune system mechanisms for the treatment of various types of cancers,” Richard Pazdur, acting director of the FDA’s office of hematology and oncology products, said in a statement. “These advancements are leading to new therapies — even in rare forms of cancer where treatment options are limited or non-existent.”

FDA officials said their approval was based on a clinical trial in which 33 of 88 patients experienced complete or partial shrinkage of their tumors. The response lasted more than six months in 86 percent of those patients, and more than a year in 45 percent.

The agency said Bavencio could cause side effects, including fatigue, muscular pain, nausea, swelling of the limbs, and the risk of the immune system attacking healthy cells or organs.