Genentech Breast Cancer Combo Gets FDA Accelerated Approval

– This Tecentriq combination is the first cancer
immunotherapy regimen approved for breast cancer –

– Triple-negative breast cancer is an aggressive disease, with high
unmet medical need –

Genentech, a member of the Roche Group ((SIX: RO, ROG, OTCQX:RHHBY),
today announced the U.S. Food and Drug Administration (FDA) has granted
accelerated approval to Tecentriq^® (atezolizumab) plus
chemotherapy (Abraxane^® [paclitaxel protein-bound particles
for injectable suspension (albumin-bound); nab-paclitaxel]) for
the treatment of adults with unresectable locally advanced or metastatic
triple-negative breast cancer (TNBC) in people whose tumors express
PD-L1, as determined by an FDA-approved test. This indication is
approved under accelerated approval based on progression-free survival
(PFS). Continued approval for this indication may be contingent upon
verification and description of clinical benefit in a confirmatory
trial(s). The FDA’s Accelerated Approval Program allows conditional
approval of a medicine that fills an unmet medical need for a serious or
life-threatening disease or condition.

https://www.benzinga.com/pressreleases/19/03/b13328303/fda-grants-genentechs-tecentriq-in-combination-with-abraxane-accelerat