Seattle Genetics Submits sBLA to Expand Adcetris Label

Adcetris

Seattle Genetics has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration seeking to expand the label for their Hodgkin's lymphoma and anaplastic large cell lymphoma treatment, Adcetris (brentuximab vedotin).

The sBLA seeks to make the anti-CD30 antibody drug conjugate approved for both re-treatment in patients with either relapsed Hodgkin's or relapsed anaplastic large cell lymphoma as well as extended duration past the current number of 16 cycles.

Adcetris first received accelerated approval by FDA in August of 2011 for the treatment of relapse in both diseases.

Their application is supported by updated data from a phase II clinical trial that explored Adcetris in two settings:

  • In one, patients previously responded to Adcetris but discontinued treatment only to have their disease return.
  • In the other, patients received extended treatment with Adcetris past 16 cycles.

When a company wants to make additions or changes to its product, it must first file a supplement to the original BLA or NDA with the U.S. FDA for approval.

Source: Seattle Genetics

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