Roche is set to voluntarily withdraw the US indication for Tecentriq (atezolizumab) in prior platinum treated metastatic urothelial carcinoma (mUC, bladder cancer) following its consultation with the US Food and Drug Administration (FDA).
The company held discussions with the FDA as part of a review of accelerated approvals with confirmatory trials that did not meet primary endpoint(s) and are yet to get regular approvals.
A monoclonal antibody, Tecentriq can potentially attach with a Programmed Death Ligand-1 (PD-L1) protein, which is expressed on tumour cells and tumour-infiltrating immune cells, inhibiting its interactions with both PD-1 and B7.1 receptors.
Roche will work with the FDA in the coming weeks to conclude the withdrawal process.
The decision does not impact other approved indications for Tecentriq. Healthcare specialists are being informed by the company of its withdrawal.
Roche noted that patients currently receiving Tecentriq for prior-platinum treated mUC should talk to their healthcare provider.
Roche chief medical officer and global product development head Levi Garraway said: “The Accelerated Approval Program allows people with difficult-to-treat cancers to receive certain new therapies earlier.
“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.”
The Accelerated Approval Program of FDA permits conditional approval of a treatment for an unmet medical need for a serious illness, with specific post-marketing requirements (PMRs) to ascertain its clinical benefit and convert to regular approval.
In 2016, Tecentriq received accelerated approval for treating prior-platinum treated mUC based on results from the IMvigor210 study (Cohort 2).
Continued approval for the indication depended upon the results of the IMvigor211 study, which failed to meet its primary endpoint of overall survival in the high PD-L1 subjects.