Roche's Polivy Combo Regime Under FDA Review For Type Of Blood Cancer

Roche Holdings AG RHHBY announced that the FDA accepted its supplemental marketing application for Polivy.
Polivy is being developed by Roche using Seagen Inc SGEN ADC technology and is currently being investigated for the treatment of several types of non-Hodgkin lymphoma (NHL).
Polivy is being used with Rituxan and cyclophosphamide, doxorubicin, and prednisone (R-CHP) for previously untreated diffuse large B-cell lymphoma (DLBCL), an aggressive blood cancer.
The FDA is expected to decide on approval by April 2, 2023.
The progression comes on the back of the results from its Phase 3 POLARIX trial.
The study showed significant improvement in median progression-free survival at a 28.2-month check-in, with the risk of disease progressions reduced by 27% with Polivy plus R-CHP, compared with R-CHOP earning itself a p-value of p=0.02.
The treatment combo also initially posted a Grade 3-4 side effect rate of 57.7% compared with 57.5% for the SOC chemo combo.
3% of patients died in the treatment arm compared with 2.3% in control, and 9.2% in the Polivy arm discontinued due to dosing compared with 13% in the Rituxan-chemo arm.
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