Adcetris (brentuximab vedotin)

by Ross Bonander

Adcetris is the brand name used to market the molecule brentuximab vedotin, which for a long time was simply known as SGN-35, manufactured by Seattle Genetics. Adcetris is the first new therapy approved for use against Hodgkin's lymphoma since 1977, and it is the first therapy ever to receive approval against anaplastic large cell lymphoma.

Drug profile

• Class: Anti-CD30 antibody drug conjugate
• Mechanism of action: Adcetris uses a monoclonal antibody linked with monomethyl auristatin E (MMAE); the antibody seeks out CD30 expressing cells and on finding them, releases the MMAE, a cytotoxic drug payload that kills the cell in question.
• Treatment type: Immunotherapy
• US approval: 2011
• Synonyms: SGN-35, brentuximab vedotin
• FDA Use-in-Pregnancy Rating: Unknown, although pregnant women should be aware of the potential for Adcetris to harm their unborn child.

What it's effective for and why

Adcetris has been approved by the US FDA for two separate indications: for the treatment of Hodgkin's lymphoma in patients who have either undergone two prior chemotherapy regimens and are not candidates for an autologous stem cell transplantation, or HL patients who have already undergone the transplant.

Adcetris has also been approved for patients with anaplastic large cell lymphoma who have failed at least one prior chemotherapy regimen.

Side effects: Overview

Each patient will likely have his or her own reactions to Adcetris, and while not everyone will experience side effects, those that do are urged to report each and every one of them to their doctor or oncology team. Adcetris has been reported to cause the following side effects: fatigue, peripheral neuropathy, neutropenia, nausea, vomiting, fever, thrombocytopenia, upper respiratory tract infections, and diarrhea.

It is extremely important for prospective patients to realize that Adcetris is very new, and because of this, it is not as well understood as other, older medications. Therefore, all patients are urged to pay close attention to any strange or unusual developments while receiving Adcetris and to report them to their health care professionals immediately. It will be many years before the toxicity profile—and the efficacy profile—of Adcetris is well understood.

Because the FDA approved Adcetris on its accelerated approval program, this means that Seattle Genetics will be required to continue to carry out clinical trials to further prove the drug's efficacy while it is on the market.

Related

Adcetris approved by the FDA

Sources

• FDA news release regarding Adcetris

Significant studies relating to Adcetris

• Oflazoglu E et al. Combination of the anti-CD30-auristatin-E antibody-drug conjugate (SGN-35) with chemotherapy improves antitumour activity in Hodgkin lymphoma. Br J Haematol. 2008 Jul;142(1):69-73.
• Younes A et al. Brentuximab vedotin (SGN-35) for relapsed CD30-positive lymphomas. N Engl J Med. 2010 Nov 4;363(19):1812-21.