Following a meeting with the Food and Drug Administration (FDA), Genentech is voluntarily withdrawing the US indication for Tecentriq® (atezolizumab) for the treatment of prior-platinum treated metastatic urothelial carcinoma.
In 2016, the FDA granted accelerated approval to Tecentriq, a programmed death-ligand 1 (PD-L1) blocking antibody, for prior-platinum treated metastatic urothelial carcinoma based on tumor response rate and duration of response data the phase 2 IMvigor210 study (ClinicalTrials.gov: NCT02108652). According to the Agency’s accelerated approval program, a drug may be approved earlier if it is intended to treat a serious condition or fills an unmet need; the approval is based on a surrogate end point that is thought to predict clinical benefit.
However, results from a subsequent confirmatory phase 3 trial (IMvigor211; ClinicalTrials.gov: NCT02302807) showed that treatment with Tecentriq did not meet the primary end point of overall survival in the PD-L1 high patient population. Continued approval for this indication was contingent upon the results of IMvigor211, the original post marketing requirement (PMR) to confirm clinical benefit. The IMvigor130 study (ClinicalTrials.gov: NCT02807636), which was subsequently designated as the PMR, will still continue until the final analysis.
“The Accelerated Approval Program allows people with difficult-to-treat cancers to receive certain new therapies earlier,” said Levi Garraway, MD, PhD, Genentech’s chief medical officer and head of Global Product Development. “While the withdrawal of Tecentriq for prior-platinum treated bladder cancer is disappointing, Tecentriq continues to demonstrate benefits across multiple cancer types and therefore remains a meaningful treatment option for many patients.”
Genentech is notifying health care professionals regarding the withdrawal of the US indication. Patients being treated with Tecentriq for prior-platinum treated urothelial carcinoma should consult their health care provider.
Genentech provides update on Tecentriq U.S. indication in prior-platinum treated metastatic bladder cancer. [press release]. South San Francisco, CA: Genentech; March 8, 2021.