FDA approves Genentech's Tecentriq for bladder cancer treatment

The Food and Drug Administration approved atezolizumab (Tecentriq) and atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) from Genentech Inc. as adjuvant treatments for adults with muscle invasive bladder cancer after cystectomy who have circulating tumor DNA molecular residual disease.

The agency also approved Signatera CDx from Natera Inc. (NASDAQ: NTRA) as a companion diagnostic device to identify patients with muscle invasive bladder cancer after cystectomy who have ctDNA molecular residual disease for adjuvant treatment with the Tecentriq products.

The approval was based on results from the IMvigor011 trial, a randomized, double-blind, placebo-controlled study that enrolled 250 patients with muscle invasive bladder cancer who had radical cystectomy with lymph node dissection and detectable molecular residual disease. Patients received either atezolizumab 1680 mg or placebo intravenously every four weeks for up to 12 cycles or one year.

The study showed a median disease-free survival of 9.9 months for atezolizumab compared to 4.8 months for placebo, with a hazard ratio of 0.64. Overall survival was 32.8 months for atezolizumab versus 21.1 months for placebo, with a hazard ratio of 0.59.

The recommended atezolizumab dose is 840 mg every two weeks, 1200 mg every three weeks, or 1680 mg every four weeks administered intravenously for up to one year. The subcutaneous formulation is dosed at 1875 mg of atezolizumab and 30,000 units of hyaluronidase every three weeks for up to one year.

The application received priority review under FDA expedited programs for serious conditions. The prescribing information includes warnings for immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation, and embryo-fetal toxicity.

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