Seattle Genetics wins new OK for Adcetris
- Seattle Genetics Inc. has secured a fourth approval for its top drug Adcetris, winning an U.S. OK for use as a second-line treatment of primary cutaneous anaplastic large cell lymphoma (pcALCL) and CD30-expressing mycosis fungoides (MF).
- The green light from the Food and Drug Administration comes over a month ahead of the drug's Prescription Drug User Fee Act (PDUFA) target action date, originally set for December 16, 2017.
- Cutaneous T-cell lymphoma (CTCL) patients make up around 4% of all non-Hodgkin lymphoma patients, and CD30-expressing MF and pcALCL are two of the most common subtypes. Current systemic therapies have low complete response rates and between 30% to 45% objective response rates, according to the company.
Adcetris (brentuximab vedotin) is an antibody-drug conjugate (ADC) directed at the CD30 antigen, and is currently in scores of clinical trials as either monotherapy or in combination.
Last week's approval in CTCL — which comes six years after the drug's initial approval — is based on data from the Phase 3 ALCANZA trial and two Phase 2 investigator-sponsored trials. In the ALCANZA study, patients treated with Adcetris experienced a significantly higher rate of objective response that lasted at least four months, at 56.3%, than the 12.5% response seen for those in the control arm.
"Our goal is to establish ADCETRIS as the foundation of care in CD30-expressing lymphomas," said company CEO Clay Siegall, in a Nov. 9 statement.
Seattle Genetics has so far made good on that goal, winning approvals in classical Hodgkin lymphoma (CHL) for patients who have failed previous treatments, CHL patients who are at high risk of relapse post stem cell transplant, and in systemic anaplastic large cell lymphoma patients who have failed at least one prior chemotherapy regimen.
Global sales of Adcetris are expected to reach $600 million in 2017.
The next approval, however, could be a major step forward for the franchise commercially. Seattle Genetics hopes to win an FDA OK as a first-line treatment for advanced Hodgkin lymphoma, based on positive data from its Phase 3 ECHELON-1 study testing the drug in combination with chemotherapy.
The company recently submitted a supplemental Biologics License Application for that indication earlier this month.
"Approval in frontline advanced Hodgkin lymphoma would open up a substantial opportunity for Adcetris and we believe could define a new standard of care in this patient population after more than four decades," said Siegall on a third quarter earnings call in October. "Our team is preparing for launch in the first half of 2018."
The company has already begun expanding its commercial team in preparation for approval, building out its sales force to over 100 staff.
Another study, dubbed ECHELON-2, is examining Adcetris as front-line therapy for mature T-cell lymphoma (peripheral T-cell lymphoma) and should also read out in 2018.
- Seattle Genetics Press release
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