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UK Grants EAMS Positive Opinion to Atezolizumab Combo in Frontline TNBC

Gina Columbus @ginacolumbusonc
Published: Thursday, Mar 14, 2019

breast cancer
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.

References

  1. 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.
  2. 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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