Roche's Obinutuzumab Short-Duration Infusion Protocol Approved in China, Reducing Administration Time from 4 Hours to 90 Minutes
Roche
Oncology Drug Research, Development, and Manufacturing
On June 24, Roche announced that the NMPA officially approved the update of the package insert for its innovative hematology oncology drug, obinutuzumab injection, adding a 90-minute rapid short infusion regimen.SDI) Solution.
It is reported that this regimen shortens the single infusion time of Obinutuzumab from the original 3~4 hours to 90 minutes, and can be applied as early as the start of the second treatment cycle for patients, with the potential to become the preferred infusion regimen for patient treatment.
The approval of the Obinutuzumab SDI dosing regimen is based on the international multicenter Phase IV clinical GAZELLE study. Data show that the safety of the Obinutuzumab SDI regimen is favorable: no patients experienced ≥Grade 3 IRR during the second cycle of SDI, and only one patient experienced Grade 3 IRR in subsequent treatment cycles, with no patients experiencing Grade 4 or 5 IRR.
In terms of time, the median infusion duration for the SDI regimen is 95-98 minutes, which is more than half shorter compared to the standard infusion regimen of 205-269.5 minutes. In terms of efficacy, the ORR for the SDI regimen is 86.7%, consistent with the data reported in the Phase III GALLIUM study (88.5%) Consistent.
Another study conducted in Chinese hospitals enrolled 208 patients with advanced non-Hodgkin lymphoma (NHL) patients. The results showed that Obinutuzumab 90-minute SDI was well tolerated. Among 814 infusions, only 2 cases (0.25%) IRR. This study further confirms the safety of the Obinutuzumab SDI regimen in Chinese patients.
Screenshot from: Insight Database official website
Overall, the successful approval of the Obinutuzumab SDI regimen in China not only provides patients with a more convenient and efficient treatment option, further reducing the burden of the disease on patients, but also enhances the clinical management level of hematological tumors in China.
