Roche Submits sBLA to FDA for Glofitamab in Combination with GemOx for Relapsed/Refractory DLBCL
Roche
Oncology Drug Research, Development, and Manufacturing
On December 5, Roche announced that the U.S. FDA had acceptedGlofitamab(Columvi®，Glofitamab) Supplemental Biologics License Application(sBLA)，With Gemcitabine and Oxaliplatin(GemOx) Combined for the treatment of relapsed or refractory (R/R)Diffuse Large B-Cell Lymphoma(DLBCL) PatientThese patients had previously received at least one line of treatment and were not eligible for autologous stem cell transplantation.
The FDA is expected to make an approval decision by July 20, 2025.
Screenshot source: Corporate official website
Previously, the standard second-line therapy for R/R DLBCL patients was high-dose chemotherapy followed by stem cell transplantation. However, not all patients are suitable for this type of treatment due to age or existing medical conditions. Although new treatment options are available, many patients still face barriers and require alternative therapeutic approaches to improve survival outcomes for these patients.
This sBLA is based on the results of the Phase III STARGLO study, which was presented at this year's European Hematology Association Congress.（EHA）Published, and recently appeared in The Lancet.
The results showed that a total of 274 DLBCL patients were enrolled, including the Columvi and GemOx combination group.（Glofit-GemOx）There were 183 patients in the rituximab combined with GemOx group.（R-GemOx）There are 91 patients; there are 172 cases.（62.8%）Previously treated once, with 102 cases having received ≥2 prior treatments.（37.2%）。
In the preliminary analysis(Deadline: March 29, 2023), Glofit-GemOx compared with RGemOxSignificant OS benefit (HR 0.59)At a median follow-up of 11.3 months, the median OS for Glofit-GemOx was not reached, while the median OS for R-GemOx was 9 months. A significant benefit of Glofit-GemOx was also observed in the PFS assessed by IRC (HR 0.37, p<0.0001) and CR rate (50.3 vs 22.0%, p<0.0001). At a median follow-up of 20.7 months, Glofit-GemOx continued to demonstrate superior median OS compared to R-GemOx:25.5 months vs 12.9 months (HR 0.62), Median PFS: 13.8 vs 3.6 months (HR 0.40), CR rate: 58.5 vs 25.3%.
Screenshot source: EHA official website
