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

tecentriq
In a phase 3 study, Tecentriq cut the risk of disease worsening or death by 38% among PD-L1-positive TNBC patients. (Roche)

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.

Free Daily Newsletter

Like this story? Subscribe to FiercePharma!

Biopharma is a fast-growing world where big ideas come along daily. Our subscribers rely on FiercePharma as their must-read source for the latest news, analysis and data on drugs and the companies that make them. Sign up today to get pharma news and updates delivered to your inbox and read on the go.

RELATED: Roche's Tecentriq posts 'unprecedented' benefit in triple-negative breast cancer

“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.

RELATED: Roche's Tecentriq hits a lung cancer slowdown in its bid to challenge Merck

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.

Suggested Articles

Bayer Chairman Werner Baumann could face a vote a no confidence from its top investor, BlackRock, Reuters reported.

When Sanofi inked a massive lease in Cambridge Crossing last year, the drugmaker found itself in prime position for another real estate deal.

Amid China's tighter grip on antibiotics use, Lilly sold Chinese rights to two legacy antibiotics and a manufacturing facility to China's Eddingpharm.