FDA Grants Accelerated Approval for Roche Holdings Tecentriq Drug for Breast Cancer

It was this week that Roche Holdings AG RHHBY announced that the Food and Drug Administration has accelerated approval to Tecentriq, an immuno-oncology drug in combination with Celgene Corporation’s CELG Abraxane for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer in patients whose tumors express PD-L1, as determined by an FDA-approved test.

Positive data from a phase III IMpassion 150 study was cited for the accelerated approval. The study had shown that the combination of the drugs significantly reduced the risk of disease worsening or death (PFS) by 40% compared with nab-paclitaxel alone.

According to Roche, the Tecentriq combination is the first cancer immunotherapy regimen to be approved in breast cancer.

“Triple-negative breast cancer is an aggressive disease that, until now, has had limited treatment options,” said Michael Heuer, CEO of Roche Diagnostics. “This assay plays a pivotal role in helping physicians identify patients that can benefit from Tecentriq therapy, providing better patient care. At Roche, we build on our capacity to research both targeted medicines and companion diagnostics under one roof, so we can provide the right treatment to the right patient at the right time.”

Disclaimer: We have no position in Roche Holdings AG Basel ADR Common Stock (OTCMKTS: RHHBY) and have not been compensated for this article.