Roche’s Tecentriq in combination with Abraxane granted FDA priority review

The FDA has determined Roche’s Tecentriq in combination with Abraxane to prospectively provide significant improvements in the diagnosis, treatment or prevention of PD-L1-positive, metastatic triple-negative breast cancer by accepting Roche’s supplemental Biologics License Application, and granting priority review for the combination, for the first line treatment of unresectable locally advanced or metastatic triple-negative breast cancer in patients whose disease expresses the PD-L1 protein, as determined by PD-L1 biomarker testing. A decision is expected by March 2019, and if approved, the combination will be the first cancer immunotherapy regimen for this disease.
Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development, said: “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. We are working closely with the FDA to bring this Tecentriq combination to people with PD-L1-positive metastatic triple-negative breast cancer as soon as possible.”