Roche's Genentech unit on Wednesday announced that the immunotherapy Tecentriq (atezolizumab) was awarded accelerated approval by the FDA for the treatment of locally advanced or metastatic urothelial carcinoma, marking the first approval of a PD-L1 inhibitor by the agency to treat this type of cancer. Specifically, the therapy was authorised for patients who have disease progression during or following platinum-based chemotherapy or whose disease worsened within 12 months of receiving platinum-based chemotherapy before or after surgery. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, remarked "Tecentriq provides [patients] with a new therapy targeting the PD-L1 pathway."
The approval was supported by safety and efficacy data from IMvigor 210 study. The drugmaker indicated that in a cohort of the study, 310 patients whose disease worsened during or following previous treatment with a platinum-based chemotherapy regimen, or who had disease progression within 12 months of platinum-based chemotherapy before or after surgery received Tecentriq on day one of 21-day cycles until unacceptable toxicity or either radiographic or clinical progression. Updated study results from which were unveiled in January showed that 14.8 percent of participants experienced at least partial tumour shrinkage, with the effect persisting for at least 13.8 months in some patients. Meanwhile, among PD-L1-positive patients, 26.0 percent experienced a tumour response versus 9.5 percent of patients who were classified as "negative" for PD-L1 expression.
Roche noted that Tecentriq will be launched in the US within one or two weeks. The therapy will be priced at about $12 500 a month.
Tecentriq was awarded priority review status by the FDA in March for the treatment of certain patients with urothelial carcinoma. The drug was previously granted breakthrough therapy designation by the agency in 2014.
For related analysis, see Spotlight On: Roche gears up for the year of atezolizumab. See also ViewPoints: Roche's pipeline keeps it busy.
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