FDA New Drug and Biologic Approvals -- 2017 Year-in-Review

Imfinzi (durvalumab)

Indication:

Locally advanced or metastatic urothelial carcinoma in patients who have disease progression with platinum-based chemotherapy

Mechanism:

Human IgG1 kappa monoclonal antibody that blocks PD-L1 binding to PD-1 and CD80, and therefore overcoming/preventing PD-L1-mediated inhibition/suppression of T-cell activation.

Dosage:

10 mg/kg IV q2wk. Continue until disease progression or unacceptable toxicity.

Approval:

Approval was based on a single-arm trial of 182 patients with locally advanced or metastatic urothelial carcinoma whose disease progressed after prior platinum-containing chemotherapy. Overall response rate was 17%.

Reference:

Powles T, et al. Efficacy and safety of durvalumab in locally advanced or metastatic urothelial carcinoma: Updated results from a phase I/II open-label study. JAMA Oncol. 2017 Sep 14;3(9):e172411.

Medscape © 2018 WebMD, LLC

Any views expressed above are the author's own and do not necessarily reflect the views of WebMD or Medscape.

Cite this: Mary L Windle. FDA New Drug and Biologic Approvals -- 2017 Year-in-Review - Medscape - Jan 11, 2018.