publication date: Apr. 21, 2017

Drugs and Targets

Tecentriq receives accelerated approval as initial treatment for advanced bladder cancer

FDA granted accelerated approval to Genentech’s Tecentriq (atezolizumab) for the initial treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin chemotherapy.

Tecentriq was previously approved for patients with locally advanced or mUC who have disease progression during or following any platinum-containing chemotherapy, or within 12 months of receiving chemotherapy before surgery or after surgery.

It is not known if Tecentriq is safe and effective in children, according to Genentech.

Bladder cancer is the most common type of urothelial carcinoma, and up to half of all people with the advanced form of the disease are unable to receive cisplatin chemotherapy as an initial treatment and therefore have a high unmet medical need. Urothelial carcinoma also includes cancers of the urethra, ureters and renal pelvis.

FDA’s Accelerated Approval Program allows conditional approval of a medicine that fills an unmet medical need for a serious condition, based on early evidence suggesting clinical benefit. The indication for Tecentriq is approved under accelerated approval based on tumor response rate and duration of response.

Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials, according to Genentech. Approval of Tecentriq is based on the Phase II IMvigor210 study, an open-label, multicenter, single-arm Phase II study that evaluated the safety and efficacy of Tecentriq in people with locally advanced or mUC, regardless of PD-L1 expression.

This is the third approval for Tecentriq in under a year. Tecentriq is also approved for the treatment of people with metastatic non-small cell lung cancer (NSCLC) … Continue reading Tecentriq receives accelerated approval as initial treatment for advanced bladder cancer

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