Roche’s Tecentriq loses bladder cancer use as FDA crackdown continues

Roche’s Tecentriq is the latest medicine to fall foul of a crackdown by the FDA on drugs that have failed to live up to their early promise.

The Swiss pharma said it is voluntarily withdrawing the US indication for the immunotherapy Tecentriq (atezolizumab) in metastatic urothelial carcinoma (mUC) previously treated with chemotherapy.

As with AstraZeneca’s Imfinzi in previously treated bladder cancer, Merck & Co’s Keytruda in previously treated metastatic small cell lung cancer, and Bristol-Myers Squibb’s Opdivo in small cell lung cancer after chemo, the FDA has asked for indications to be axed after the required overall survival data failed to emerge.

Roche said its decision was made in consultation with the FDA as part of an industry-wide review of accelerated approvals.

The FDA is reviewing drugs quickly approved on the basis of early stage trial data, where phase 3 data failed to confirm efficacy.

Roche will work with the FDA over the coming weeks to complete the withdrawal process.

This decision does not affect other approved indications for Tecentriq, Roche noted in a statement.

Roche is notifying healthcare professionals about this withdrawal and said patients being treated with Tecentriq in this indication should discuss their care with their healthcare provider.

Tecentriq was granted accelerated approval in 2016 for the treatment of prior-platinum treated mUC based on the results from cohort 2 of the IMvigor210 study

Continued approval for this indication was contingent upon the results of IMvigor211, the original post-marketing requiremnent for the prior-platinum treated mUC indication.

This study did not meet its primary endpoint of overall survival in the PD-L1 high patient population and the FDA later FDA designated the IMvigor130 study as the post-marketing requirement, which will still continue until the final analysis.

But with Pfizer/Merck KGaA’s Bavencio approved in this indication, Roche has decided to call it a day in this market niche.

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