The approval was based on data from an open-label phase 1/2 trial in patients aged 1 to 21 years that included 26 patients with relapsed or refractory, systemic ALK-positive ALCL after at least 1 systemic treatment.
Study results suggest allogeneic SCT as standard consolidation therapy in pediatric patients with progression during frontline therapy or relapse of a CD3-positive ALCL.
In 2016, the World Health Organization classified BIA-ALCL as a novel lymphoma.
Overall survival at 5 years was 100% with the reduced-intensity conditioning regimen compared with 48.5% with the myeloablative conditioning regimen.
FDA requested recall to protect women from breast implant-associated anaplastic large cell lymphoma
The risk of breast implant-associated anaplastic large cell lymphoma may be higher than previously reported for women who receive textured implants, according to researchers.
The US FDA provided updated information to women with breast implants and their health care providers on the risk of developing a specific type of lymphoma.
The safety of breast implants has not been confirmed despite widespread use.
The U.S. Food and Drug Administration has approved brentuximab vedotin for the treatment of adult patients with pcALCL or CD30-expressing mycosis fungoides who have received prior systemic therapy.
