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The U.S. Food and Drug Administration ( FDA ) has granted accelerated approval to Durvalumab ( Imfinzi ) for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following Platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with Platinum-containing chemotherapy.

The FDA also approved the VENTANA PD-L1 ( SP263 ) Assay (Ventana Medical Systems ) as a complementary diagnostic for the assessment of the PD-L1 protein in formalin-fixed, paraffin-embedded urothelial carcinoma tissue.

Approval was based on one single-arm trial of 182 patients with locally advanced or metastatic urothelial carcinoma whose disease progressed after prior platinum-containing chemotherapy. Durvalumab, 10 mg/kg intravenously, was administered every 2 weeks.
Confirmed objective response rate ( ORR ) as assessed by blinded independent central review per RECIST 1.1, was 17.0% ( 95% CI: 11.9, 23.3 ).
At the data cutoff for the ORR analysis, median response duration was not reached ( range: 0.9+ to 19.9+ months ).
ORR was also analyzed by PD-L1 expression status as measured by VENTANA PD-L1 ( SP263 ) Assay. In the 182 patients, the confirmed ORR was 26.3% ( 95% CI: 17.8, 36.4 ) in 95 patients with a high PD-L1 score and 4.1% ( 95% CI: 0.9, 11.5 ) in 73 patients with a low or negative PD-L1 score.

The most common adverse reactions in at least 15% of patients were fatigue, musculoskeletal pain, constipation, decreased appetite, nausea, peripheral edema, and urinary tract infection.
Grade 3-4 adverse events were seen in 43% of patients.
Infection and immune-related adverse events such as pneumonitis, hepatitis, colitis, thyroid disease, adrenal insufficiency, and diabetes were also seen with Durvalumab.

The recommended dose of Durvalumab is 10 mg/kg, administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity. ( Xagena )

Source: FDA, 2017

XagenaMedicine2017