FDA grants priority review to Roche's filing for Tecentriq in triple-negative breast cancer

Roche said Tuesday that the FDA granted priority review to a filing seeking approval of Tecentriq (atezolizumab) plus chemotherapy for the first-line treatment of unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) in people whose disease expresses the PD-L1 protein. The agency is expected to make a decision on approval by March 12, 2019.

According to Roche, if approved, the Tecentriq combination would be the first cancer immunotherapy regimen for the treatment of PD-L1-positive, metastatic TNBC. Sandra Horning, Roche's head of global product development, said "Tecentriq in combination with [Abraxane] has the potential to meaningfully advance treatment for people with PD-L1-positive, metastatic triple-negative breast cancer."

The marketing application is based on results from the Phase III IMpassion130 study, with data presented last month at the European Society for Medical Oncology (ESMO) congress showing that Tecentriq in combination with Celgene's Abraxane (nab-paclitaxel) significantly reduced the risk of disease worsening or death compared with Abraxane alone. Median progression-free survival (PFS) in the two groups was 7.2 months and 5.5 months, respectively, while in the PD-L1-positive population, median PFS was 7.5 months and 5 months, respectively.

Roche noted that it has seven ongoing Phase III studies investigating Tecentriq in TNBC, including early and advanced stages of the disease. The PD-L1 inhibitor is already approved in the EU, US and more than 80 countries for people with previously treated metastatic non-small-cell lung cancer and for certain types of untreated or previously treated metastatic urothelial carcinoma.

For related analysis, see ESMO 2018 analysis: Roche delivers an immunotherapy breakthrough in triple negative breast cancer albeit in a narrowed patient population.

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