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

Mary L Windle, PharmD

Disclosures

January 11, 2018

In This Article

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.

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