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FDA reassessing Tecentriq combo therapy for breast cancer after failed study

September 8, 2020

failed Phase 3 clinical trial, IMpassion131, evaluating the combination of Roche’s (OTCQX:RHHBY +1.0%) Tecentriq (atezolizumab) and chemo agent paclitaxel for the first-line treatment of patients with PD-L1-positive metastatic triple-negative breast cancer (mTNBC), an unapproved indication for the doublet therapy, may have implications for Tecentriq’s current approved use in TNBC.

The FDA says its continued accelerated approval of Tecentriq plus Bristol Myers Squibb’s (BMY -2.6%) Abraxane (paclitaxel protein-bound particles for injectable suspension [albumin-bound]; nab-paclitaxel) for first-line unresectable locally advanced PD-L1-expressing TNBC, granted in March 2019, may be contingent on proving benefit in additional studies. It is continuing its review of results from ‘131 and will announce any changes to Tecentriq’s prescribing information as appropriate.

The agency based its accelerated nod on positive progression-free survival data from another Phase 3, IMpassion130.

The Tecentriq combo was the first cancer immunotherapy regimen approved for breast cancer.

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