Roche's I-O drug Tecentriq picks up key first-in-class breast cancer nod

In a first for the immuno-oncology field, Roche’s Tecentriq has a big new approval in breast cancer. And once again, the Swiss drugmaker has nabbed a piece of the immuno-oncology market all for itself.

On Monday, the FDA greenlighted the immuno-oncology drug, in combination with Celgene chemo drug Abraxane, as a treatment for patients with triple-negative breast cancer (TNBC) whose tumors express the protein PD-L1. The go-ahead makes it the first immunotherapy regimen cleared in TNBC—and in breast cancer in general.

Regulators based their positive decision on data presented last fall that showed that adding Tecentriq to Abraxane in newly diagnosed patients could pare down the risk of disease worsening or death by 20%. The duo staved off progression by a median 7.2 months, compared with 5.5 months for Abraxane on its own.

Now, Roche will lead the way in TNBC without market competition from its PD-1/PD-L1 nemeses—at least for now. Tecentriq’s other two therapy areas, bladder cancer and lung cancer, are ultracrowded, thanks to drugs such as Merck’s Keytruda and Bristol-Myers Squibb’s Opdivo, both of which hit the scene before Tecentriq did.

But when it comes to breast cancer, Roche is used to leading the way, and the company will no doubt lean on its marketing expertise—gleaned through years selling drugs like Herceptin and, more recently, Perjeta and Kadcyla—to get Tecentriq off the ground.

Meanwhile, the approval is an exciting one for doctors and patients who've battled the notoriously tough-to-treat disease for years with few good options.

"The response from the physician community has been phenomenal," Amreen Husain, M.D., global development team leader for Roche immuno-oncology, said in an October interview. "They have expressed to us that they feel that this is really an unprecedented, transformative benefit for patients and they can’t wait to be able to bring this to their patients."

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