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# Seattle Genetics sBLA for Adcetris OK’d in 2 Weeks
- URL: https://www.fdaweb.com/seattle-genetics-sbla-for-adcetris-okd-in-2-weeks/
- Published: 2018-11-16T12:00:00.000Z
- Updated: 2026-09-15T00:45:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142845

In less than two weeks after submitting a supplemental BLA, FDA approved a Seattle Genetics submission for Adcetris (brentuximab vedotin) for previously untreated systemic anaplastic large cell lymphoma or other CD30-expressing peripheral T-cell lymphomas ([see earlier story](https://www.fdaweb.com/breakthrough-designation-for-seattle-genetics-adcetris/)). The agency [says it ](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm626079.htm?utm%5Fcampaign=FDA%20approves%20new%20first-line%20treatment%20for%20peripheral%20T-cell&utm%5Fmedium=email&utm%5Fsource=Eloqua)reviewed the sBLA under its [Real-Time Oncology Review](https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/OCE/ucm612927.htm?ref=fdaweb.com), which allows it to review much of the data earlier, after the clinical trial results become available and the database is locked, and before the information is formally submitted. “This allows the FDA to begin its analysis of the data earlier, and provide feedback to the sponsor on how they can most effectively analyze the data to answer key regulatory questions,” the agency says. “The pilot focuses on early submission of data that are the most relevant to assessing safety and effectiveness of the product. Then, when the sponsor submits the application with the FDA, the review team will already be familiar with the data and in a better position to conduct a more efficient, timely, and thorough review.”

Adcetris is a monoclonal antibody that binds to the CD30 protein found on some cancer cells. It is now approved to treat previously untreated systemic anaplastic large cell lymphoma (ALCL) and other CD30-expressing PTCLs in combination with chemotherapy. Adcetris was previously approved by the FDA to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL), cHL after relapse, cHL after stem cell transplant when a patient is at a high risk of relapse or progression, systemic ALCL after failure of other treatment, and primary cutaneous ALCL or CD30-expressing mycosis fungoides after failure of other treatment.