FDA grants accelerated approval to glofitamab-gxbm for selected relapsed or refractory large B-cell lymphomas
Regulatory approval: On June 15, 2023 (announced June 16), the FDA granted accelerated approval to glofitamab-gxbm (Columvi) for relapsed or refractory diffuse large B-cell lymphoma (DLBCL, NOS) or large B-cell lymphoma arising from follicular lymphoma after ≥2 prior systemic therapies. Approval was supported by the single-arm NP30179 study, which reported a 56% objective response rate with 43% complete responses and an estimated median duration of response of 18.4 months among responders. Labeling includes a Boxed Warning for cytokine release syndrome.
FDA accelerated approval (Project Orbis)
On June 15, 2023, the US FDA granted accelerated approval to glofitamab-gxbm (Columvi; Genentech) for relapsed or refractory DLBCL, NOS or LBCL arising from follicular lymphoma, after ≥2 lines of systemic therapy.
Supporting evidence
The decision was based on NP30179 (NCT03075696), an open-label, multicenter, single-arm trial evaluating efficacy in 132 patients. The population included 80% DLBCL, NOS and 20% LBCL arising from follicular lymphoma; patients had received a median of 3 prior lines (range 2–7). Patients with active or prior CNS lymphoma were excluded.
Primary efficacy measures were objective response rate (ORR) and duration of response (DOR) by independent review using 2014 Lugano criteria. Reported outcomes:
- ORR: 56% (95% CI, 47–65)
- Complete response: 43%
- Median time to response: 42 days
- Among responders (median follow-up 11.6 months), estimated median DOR: 18.4 months (95% CI, 11.4–not estimable); 9-month DOR estimate: 68.5% (95% CI, 56.7–80.3)
Safety and administration notes from labeling
Label includes a Boxed Warning for serious or fatal CRS. In a 145-patient safety population, CRS occurred in 70% (grade ≥3, 4.1%), ICANS in 4.8%, serious infections in 16%, and tumor flare in 12%. The regimen uses obinutuzumab pre-treatment followed by step-up dosing and then 30 mg every 21 days for up to 12 cycles.
The FDA review occurred under Project Orbis; Swissmedic review was noted as ongoing at the time.