The United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted an Early Access to Medicines Scheme (EAMS) positive scientific opinion to atezolizumab (Tecentriq) in combination with nab-paclitaxel (Abraxane) for patients with unresectable locally advanced or metastatic PD-L1–positive triple-negative breast cancer (TNBC).
The EAMS opinion follows the March 2019 FDA approval for the frontline regimen for patients with unresectable locally advanced or metastatic PD-L1–positive TNBC, also based on the double-blind phase III IMpassion130 trial. The FDA approval of the atezolizumab combination in this setting is contingent on the results of a confirmatory trial.
- Early Access to Medicines Scheme (EAMS) Scientific Opinion: Atezolizumab as 1st Line Treatment of Adults With Unresectable Locally Advanced Or Metastatic Triple-Negative Breast Cancer (TNBC) Whose Tumours Have PD-L1 Expression ≥ 1%. Gov.UK. Published March 13, 2019. https://bit.ly/2F68G2v. Accessed March 14, 2019.
- Schmid P. IMpassion130: Results from a global, randomised, double-blind, phase 3 study of atezolizumab (atezo) + nab-paclitaxel (nab-P) vs placebo + nab-P in treatment-naive, locally advanced or metastatic triple-negative breast cancer (mTNBC). In: Proceedings from the 2018 ESMO Congress; October 19-23, 2018; Munich, Germany. Abstract LBA1_PR.
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