publication date: May. 5, 2017

Drugs and Targets

FDA grants an accelerated approval for AstraZeneca’s Imfinzi for urothelial carcinoma

FDA granted accelerated approval to durvalumab (trade name 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.

Imfinzi is sponsored by AstraZeneca UK Ltd.

FDA also approved the VENTANA PD-L1 (SP263) Assay (Ventana Medical Systems Inc.) 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 two weeks. Confirmed objective response rate 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 … Continue reading FDA grants an accelerated approval for AstraZeneca’s Imfinzi for urothelial carcinoma

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