Roche (RHHBY) Withdraws Bladder Cancer Indication for Tecentriq
Roche RHHBY announced that it is voluntarily withdrawing the indication of prior-platinum-treated metastatic urothelial carcinoma (mUC, bladder cancer) for immuno-oncology drug, Tecentriq (atezolizumab), in the United States.
We remind investors that Tecentriq was granted accelerated approval in 2016 for the treatment of prior-platinum-treated mUC based on the results from the IMvigor210 study (cohort 2).
The continued approval for this indication was contingent upon the results of IMvigor211, the original post marketing requirements (PMR) 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.
As a result, the FDA designated the IMvigor130 study as the PMR, which will continue until the final analysis. Roche has decided to voluntarily withdraw this indication in recognition of the principles of the Accelerated Approval Program, as it believes the treatment landscape in prior-platinum (second-line) mUC to have rapidly evolved with the emergence of new treatment options.
Roche’s stock has gained 2.2% in the past year compared with the industry’s growth of 10.5%.
Tecentriq generated sales of CHF 2.7 billion in 2020, up 55%.
Roche’s Tecentriq is already approved in the United States, the EU and other regions around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of NSCLC, small cell lung cancer, certain types of metastatic urothelial cancer, PD-L1-positive metastatic triple-negative breast cancer and hepatocellular carcinoma.
While the uptake of Tecentriq has been strong, it is currently facing stiff competition from immuno-oncology therapies like Merck’s MRK Keytruda and Bristol-Myers’ BMY Opdivo in various indications. AstraZeneca’s AZN Imfinzi is also approved for some of these indications.
Roche currently carries a Zacks Rank #5 (Strong Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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