A unanimous recommendation for Adcetris for lymphoma

Brentuximab vedotin is one step closer to being approved for Hodgkin lymphoma and anaplastic large cell lymphoma after an advisory panel voted that it does provide a viable new treatment option for patients. We reported on the lymphoma drug, which has a proposed brand name of Adcetris, when the results of a phase 2 trial were announced at the American Society of Hematology meeting this past December.

The FDA advisory committee voted 10-0 to recommend accelerated approval for brentuximab vedotin in relapsed or refractory Hodgkin lymphoma and ALCL, which means that follow-up trials will need to confirm benefit before it can get full approval. The FDA also granted it priority review, meaning an approval could come as early as Aug. 30.

Brentuximab vedotin targets the CD30 antigen on the surface of lymphoma cells. Side effects include peripheral neuropathy, fatigue, nausea, upper respiratory tract infection and diarrhea.

Another interesting note is that brentuximab vedotin combines a CD30-targeted antibody with the cancer toxin auristatin. It has been touted as the first possible approved antibody-drug conjugate (ADC). T-DM1 (also called trastuzumab emtansine) also falls in this category and combines the approved antibody Herceptin with the drug maytansine (the DM1 part). It has shown potential against breast cancer.

While this is considered a new class of drugs, Mylotarg (gemtuzumab ozogamicin), approved in 2001, is also a type of conjugate, combining an antibody with a calicheamicin. Ironically, Mylotarg, after spending about 10 years on the market to treat acute myeloid leukemia, was pulled after follow-up trials revealed it offered no benefit. Let's hope brentuximab vedotin and T-DM1 don't share a similar fate. So, while brentuximab vedotin may not necessarily be the first approved antibody-drug conjugate, it may well be the only one for a time.