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FDA Approves Imfinzi for Urothelial Carcinoma
FDA news release; 2017 April 27
The FDA granted accelerated approval to Imfinzi (durvalumab) for the treatment of locally advanced or metastatic urothelial carcinoma.
Indications: Imfinzi is a programmed death-ligand 1 blocking antibody indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression:
- During or following platinum-containing chemotherapy.
- Within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
Dosage and administration: Administer 10 mg/kg as an intravenous infusion over 60 minutes every 2 weeks.
Efficacy and safety: Approval is based on one single-arm trial showing overall objective response rate (ORR) of 17%; this rate was ~26% in patients with a high PD-L1 score and ~4% in those with a low or negative PD-L1 score.
Adverse reactions: The most common adverse reactions are fatigue, musculoskeletal pain, constipation, decreased appetite, nausea, peripheral edema, and urinary tract infection.
Durvalumab (Imfinzi). [news release]. Silver Spring, MD: FDA May 1, 2017. https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm555930.htm. Accessed May 1, 2017.
Imfinzi [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP. 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761069s000lbl.pdf. Accessed May 1, 2017.