FDA expert group 7:2 supports the retention of Tecentriq triple-negative breast cancer indication

Recently, the FDA held a three-day meeting on the accelerated approval of PD-1/L1 immuno-oncology drugs.

In March 2019, PD-L1-positive patients' progression-free survival (PFS) results based on the IMpassion130 study of atelizumab combined with Abraxane (albumin paclitaxel) in the treatment of PD-L1-positive metastatic triple-negative breast cancer (TNBC) (7.

The IMpassion131 study is a confirmatory test for mTNBC indications.

There are several factors that can explain the difference between the results of "IMpassion130" and "IMpassion131".

In the report, Roche expressed confidence to see the benefits of atelizumab combined with Abraxane in the treatment of TNBC patients in the next confirmatory trial.

Chui said that Roche discussed several ways to obtain confirmatory clinical trial data with the FDA in December last year, including repeating the original key clinical trial.

Tomorrow, another indication of atelizumab approved by the FDA will also face the discussion of the expert group.