Shares in Seattle Genetics were on the rise yesterday as investors welcomed news that US regulators are to review extended use of Adcetris in two types of lymphoma.
The US Food and Drug Administration (FDA) will assess a supplemental Biologics License Application for the use of Adcetris (brentuximab vedotin) for retreatment and extended duration beyond 16 cycles of therapy in relapsed Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL).
The filing is based on results from a Phase II clinical trial with two treatment arms, in which 70% of evaluable patients retreated with the drug achieved an objective response, including nine complete remissions and seven partial remissions.
The overall objective response rate with extended treatment was 88%, including 76% complete remissions and 12% partial remissions.
In addition, Adcetris was found to be generally well tolerated in both settings, with common side effects including neuropathy and fatigue.
Adcetris is an antibody-drug conjugate directed to CD30, a defining marker of HL and sALCL, which won a speedy approval in the US back in August 2011 for relapsed HL and relapsed sALCL.
The FDA is expected to reach a decision on the sBLA by September 14.