New drug for two types of lymphoma

Today, the Food and Drug Administration approved Adcetris (brentuximab vedotin) for Hodgkin lymphoma patients and patients with a rare type of non-Hodgkin lymphoma called anaplastic large cell lymphoma (ALCL). Adcetris is the first drug approved for Hodgkin lymphoma since 1977 and the first to be particularly designated for ALCL. The drug is specifically for Hodgkin lymphoma patients who have received an autologous stem cell transplant, which uses the patient's own bone marrow for marrow-damage repair, and who have had at least two prior chemotherapy treatments and cannot receive a transplant. It is also indicated for ALCL patients whose disease has progressed after one prior chemotherapy treatment.Adcetris is an antibody-drug conjugate, which works by having the monoclonal antibody direct the chemotherapy drug monomethyl auristatin E (MMAE) to target the CD30-positive Reed-Sternberg cells, a defining characteristic of Hodgkin lymphoma. This approach allows the drug to directly reach cancer cells and spare healthy cells. The approval for Hodgkin lymphoma is based on positive results from a phase 2, 102-patient trial in which 73 percent of patients achieved a partial or complete response with patients responding to therapy for an average of 6.7 months. Positive results for ALCL came from a single 58-patient trial in which 86 percent of patients had a partial or complete response and responded for a median of 12.6 months.The most common side effects include neutropenia, peripheral sensory neuropathy, fatigue, nausea, upper respiratory tract infection and diarrhea.The drug received accelerated approval, which means follow-up trials will be conducted to confirm the drug's benefit. Seattle Genetics plans to make the drug available to patients next week and has established a patient assistance program, SeaGen Secure, which can be reached by calling 855-473-2436.