FDA alert on safety of atezolizumab combo trial

The US Food and Drug Administration is alerting health care professionals, oncology clinical investigators, and patients that a clinical trial studying the use of atezolizumab, marketed by Roche (ROG: SIX) under the trade name Tecentriq, and paclitaxel in patients with previously untreated inoperable locally advanced or metastatic triple negative breast cancer (mTNBC) showed the drug combination did not work to treat the disease.

Atezolizumab in combination with paclitaxel is not approved for use in breast cancer. However, atezolizumab in combination with paclitaxel protein-bound (Abraxane) - a different combination therapy - is currently approved for the treatment of adult patients with mTNBC whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells of any intensity covering ≥ 1% of the tumor area), as determined by an FDA-approved test. Continued approval of atezolizumab in combination with paclitaxel protein-bound may be contingent on proven benefit of the treatment in additional trials.

Health care professionals should not replace paclitaxel protein-bound (Abraxane) with paclitaxel in clinical practice, the FDA warns.