- USPLabs agrees to recall and destroy dietary supplement following FDA actions
- Senate passes Drug Quality and Security Act
- FDA advisory panel to consider OTC status of NSAIDs
- Diplomat becomes distributor of recently approved cancer drug
- 21 health industry groups address FDA on proposed changes to generic drug label rules
SILVER SPRING, Md. — The Food and Drug Administration has approved a new biotech drug for treating two types of lymphoma, the agency said Friday.
The FDA announced the approval of Seattle Genetics' Adcetris (brentuximab vedotin) to treat Hodgkin's lymphoma and a rare lymphoma called systemic anaplastic large-cell lymphoma. Adcetris combines an antibody with a drug, allowing the antibody to direct the drug to CD30, a target on lymphoma cells. The FDA said Adcetris was the first new treatment approved by the agency for HL since 1977 and the first approved specifically for ALCL.
The drug is designed for use by patients whose HL has progressed after stem-cell transplant or two chemotherapy treatments, as well as ALCL patients whose disease has progressed after one chemotherapy treatment.
"Early clinical data suggest that patients who received Adcetris for Hodgkin's lymphoma and systemic anaplastic lymphoma experienced a significant response to the therapy," FDA Office of Oncology Products director Richard Pazdur said.