FDA Grants Priority Review to Brentuximab sBLA for Cutaneous T Cell Lymphoma

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At the median follow-up 22.9 months, 56.3% of patients in the BV arm achieved a significantly superior objective global response lasting at least 4 months vs 12.5% of patients in the IC arms.
At the median follow-up 22.9 months, 56.3% of patients in the BV arm achieved a significantly superior objective global response lasting at least 4 months vs 12.5% of patients in the IC arms.

The US Food and Drug Administration (FDA) granted Priority Review to a supplemental Biologics License Application (BLA) for brentuximab vedotin (BV) for the treatment of patients with cutaneous T cell lymphoma (CTCL).1

BV was previously assigned Breakthrough Therapy Designation for the treatment of patients with primary cutaneous anaplastic large cell lymphoma who failed previous therapy and required systemic therapy, and for patients with CD30-expressing mycosis fungoides.

The FDA granted priority review based on data from the phase 3 ALCANZA trial (ClinicalTrials.gov Identifier: NCT01578499), for which researchers randomly assigned 128 patients with CTCL to receive brentuximab 1.8 mg/kg every 3 weeks vs investigator's choice (IC), which included methotrexate 5-50 mg once weekly or bexarotene 300 mg/m2 once daily.

At the median follow-up 22.9 months, 56.3% of patients in the BV arm achieved a significantly superior objective global response lasting at least 4 months vs 12.5% of patients in the IC arms, demonstrating a between-group difference of 43.8% (95% CI, 29.1-58.4; P < .0001).2

Patients in the BV arm also achieved significantly improved complete response rates, progression-free survival, and reduction of symptom burden during treatment.

RELATED: Prolonged PFS With Brentuximab Vedotin in Cutaneous T Cell Lymphoma

The most frequently reported adverse events (AE) associated with BV are anemia, peripheral sensory neuropathy, nausea, diarrhea, fatigue, and neutropenia.

The FDA has set the action date for December 16, 2017.

References

  1. FDA accepts supplemental biologics license application and grants priority review for Adcetris (brentuximab vedotin) in cutaneous T-cell lymphoma [press release]. Bothell, WA: Seattle Genetics; August 16, 2017. http://investor.seagen.com/phoenix.zhtml?c=124860&p=irol-newsArticle&ID=2294166. Accessed August 16, 2017.
  2. Prince HM, Kim YH, Horwitz SM, et al. Brentuximab vedotin or physician's vhoice in CD30-positive cutaneous T-cell lymphoma (ALCANZA): an international open-label, randomised, phase 3, multicentre trial. Lancet. 2017;390(10094):555-66. doi: 10.1016/S0140-6736(17)31266-7

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