Roche Holdings' Tecentriq Drug Gets FDA Accelerated Approval for Breast Cancer

02:16 03/16/2019

The U.S. Food & Drug Administration (FDA) has granted accelerated approval to Roche Holdings' RHHBY Tecentriq® (atezolizumab) in combination with Abraxane accelerated approval for people with PD-L1-positive, metastatic triple-negative breast cancer.

Abraxane belongs to Celgene Corporation.

The company said in a press release that 'this indication is approved under accelerated approval based on progression-free survival (PFS). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). The FDA’s Accelerated Approval Programme allows conditional approval of a medicine that fills an unmet medical need for a serious or life-threatening disease or condition.'

It was positive data from a phase III IMpassion 150 study that 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.

“The FDA approval of this Tecentriq combination is an important treatment advance for people with PD-L1-positive, metastatic triple-negative breast cancer, a disease with high unmet medical need,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “This Tecentriq combination is the first cancer immunotherapy regimen to be approved in breast cancer, representing a meaningful step forward in the understanding of this disease.”

“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.”


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