- 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.
- Price Action: RHHBY shares are down 1.84% at $41.53 on the last check Tuesday.
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