Roche's Tecentriq blazes toward first-in-class breast cancer nod with FDA 'priority' tag

Roche’s Tecentriq is on its way to becoming the first immuno-oncology drug with an approval in triple negative breast cancer, and that path just got shorter.

On Tuesday, the FDA bestowed its priority review designation on the drug in the tough-to-treat cancer type as part of a regimen containing Celgene chemo med Abraxane. Specifically, Roche is seeking an indication in previously untreated patients whose tumors express biomarker PD-L1, and it should have a decision from regulators by March 12, 2019.

The regulatory speed-up follows results from Roche’s IMpassion130 study, which showed that adding Tecentriq to Abraxane could pare down the risk of disease worsening or death by 38% in PD-L1-positive patients. The combo staved off cancer progression for 7.5 months, compared with 5 months for the control group.

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“Tecentriq in combination with nab-paclitaxel has the potential to meaningfully advance treatment for people with PD-L1-positive, metastatic triple-negative breast cancer. People need more options for this type of breast cancer, which is particularly difficult to treat,” Sandra Horning, M.D., Roche’s chief medical officer and head of global product development, said in a statement.

If Tecentriq can pick up a green light, it’ll be the first drug from its ultra-competitive class of PD-1/PD-L1 cancer-fighters to do so in TNBC. And when it comes to breast cancer, Roche feels perfectly comfortable leading the way; it’s done so for years with behemoth Herceptin, and it’s working to continue that legacy with newer therapies Kadcyla and Perjeta, too.

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Those drugs, along with Tecentriq, will be key for the Swiss drugmaker down the line as biosimilar attackers go after Herceptin and fellow elderly blockbusters Rituxan and Avastin. So far, though, Tecentriq has had trouble measuring up to the competition in the all-important lung cancer market, making a potential TNBC indication all the more crucial.