Early access to novel drug for Hodgkin lymphoma patients is in the works


When we hear promising results of a new treatment, especially one that provides a new therapy option to patients who otherwise don't have any, we want to share that news with our readers. However, we do know that for a majority of patients, that news can't come soon enough. While the data may be promising, often patients are only able to get access to an investigational drug through a clinical trial, which may be limited to a single cancer center on the other side of the country. And it may be years until that agent is available to them as an approved drug. But for Hodgkin lymphoma patients who have relapsed after an autologous stem cell transplant, there is hopeful news that brentuximab (SGN-35), a novel agent targets the CD30 antigen on the surface of Hodgkin lymphoma cells, could be available via an early access program early next year. Seattle Genetics, the manufacturer of the drug, announced the program today, which coincided with a press conference releasing results of a phase 2 trial with brentuximab. Although a date hasn't been given for the program's launch, CEO of Seattle Genetics Clay Seigall projected it could be early next year. This is in addition to Seattle Genetics submitting the drug to the FDA for approval in the next few months--not only for Hodgkin lymphoma patients after transplant failure, but also for relapsed/refractory anaplastic large cell lymphoma, a rare but aggressive type of non-Hodgkin lymphoma.Dr. Robert Chen, at City of Hope in California, will be presenting his study results tomorrow at a session during the annual meeting of the American Society of Hematology. Some of the study results were presented at today's ASH press conference, including data showing 34 percent of patients had a complete remission with the drug. And after one year, the median duration of remission has not yet been reached--meaning that after one year, more than half of patients in complete remission have yet to relapse. Tumor shrinkage occurred in 94 percent of patients, with the response lasting a median of 29 weeks. More data will be available after tomorrow morning's formal presentation. Brentuximab is administered as a 30-minute infusion and is not combined with other treatments, which limits its toxicity. However, about half of the patients in the trial developed peripheral neuropathy, which results in a stinging pain or numbness in the hands or feet. In most patients, the side effect went away once the drug was continued or treatment completed. Other common side effects included fatigue, nausea, upper respiratory tract infection and diarrhea. For more information about brentuximab, watch for additional ASH coverage in the Winter issue of CURE and an upcoming issue of CURExtra (you can sign up for the e-newsletter here).

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