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on the front line

FDA Approves New Treatment for Lymphoma First Designed at Sylvester

Offering hope to lymphoma patients who have exhausted their treatment options, the Food and Drug Administration approved a new drug in August, which was based on an antibody developed at the Miller School of Medicine. Brentuximab vedotin (SGN35), now sold as Adcetris, 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.

Humanized by Seattle Genetics, Inc., SGN35 includes a monoclonal antibody that Eckhard Podack, M.D., Ph.D., Sylvester Distinguished Professor of Medicine and Chairman of the Department of Microbiology and Immunology, developed in 1992 while studying how killer cells attack cancer and virus-infected cells. In a stroke of serendipity, the antibody his group generated happened to target CD30, a molecule prominently displayed on some lymphomas.

Patient Archie McNealy (left) visits with oncologist Dr. Denise Pereira.

In 1999, the University of Miami licensed the antibody to Seattle Genetics, which paired it with a potent chemotherapeutic agent to create a novel biologic therapy that seeks out CD30, attacking the cancer cells while leaving healthy tissue alone. In early trials conducted at Sylvester and four other sites, many patients with advanced HL and ALCL who failed standard therapies, went into complete remission.

“This agent is the first new FDA approved treatment in years for CD30-positive lymphomas, 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 Sylvester’s SGN35 trials. “It shows great promise for patients with poor treatment options.” Among them 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.’’

Dr. Eckhard Podack (left), Archie

McNealy and Dr. Joseph Rosenblatt discuss the origins and benefits of SGN35 during a press conference.

“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.’’ So normal, McNealy just re-enrolled in college. Podack is happy his team’s basic science research will help patients he’ll never meet, as well, perhaps, as 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 needs it,’’ Podack said.


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