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8.26.2011

FDA Approves New Lymphoma Drug Based on Miller School Research

Offering hope to lymphoma patients who have exhausted their treatment options, the Food and Drug Administration just approved a new drug which was based on an antibody developed at the Miller School of Medicine and has proven effective in recent clinical trials against Hodgkin’s lymphoma (HL) and anaplastic large cell lymphoma (ALCL) in patients for whom standard therapies failed.

Brentuximab vedotin (SGN35), now sold as Adcentris, was developed using a monoclonal antibody that Eckhard Podack, M.D., Ph.D., Sylvester Distinguished Professor of Medicine and Chairman of the Department of Microbiology and Immunology, generated in 1992 that targeted CD30, a molecule prominently displayed on some lymphomas.

In 1999, the University of Miami licensed the antibody to Seattle Genetics, which paired it with a potent cell-killing agent, monomethyl auristatin (MMAE), creating a novel biologic therapy that seeks out CD30 and delivers MMAE to cancer cells while leaving healthy tissue alone. In initial phase 1 and phase 2 trials conducted at Sylvester Comprehensive Cancer Center and four other cancer centers, many patients with advanced HL and ALCL who failed standard therapies went into complete remission.

“This agent is the first new treatment in years for CD30-positive lymphomas that have failed standard therapy, which is important for patients who did not benefit from chemotherapy and autologous transplant,’’ said Joseph Rosenblatt, M.D., professor of medicine, interim director of Sylvester, and principal investigator of several Sylvester trials testing SGN35. “SGN35 shows great promise for patients with poor prognoses.”

One such patient is Archie McNealy, a 30-year-old Miami resident who has endured a battery of chemotherapies since his battle against Hodgkin’s began in 2004. When he was referred to Sylvester this spring, he was in “rough shape,’’ with few, if any, options left.

“I was feverish. My joints were so tight I could barely walk. My skin was shedding. I had large tumors in my armpits and groin,’’ McNealy recalls. “But after two or three doses of SGN35 the tumors were gone. Now I’m pretty much back to normal.’’

Indeed, McNealy just re-enrolled in college.

Podack is happy that his basic science research will help patients he will never meet, and perhaps, also two people who are very dear to him. Last year, his best friend from high school and one of his best students were diagnosed with Hodgkin’s lymphoma. “I’m really glad this new therapy will be available to them – and to anybody else – who may need it,’’ Podack said.

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