DISCLAIMER: This publication is intended for healthcare professionals. The information provided aims to update on medication safety issues and should not substitute clinical judgement. While reasonable care has been taken to verify the accuracy of the information at the time of publication, the NPRA shall not be held liable for any loss arising from the use of or reliance on this publication.
Overview
In Malaysia, Columvi® (glofitamab) solution for infusion is indicated for the treatment of adult patients with:
- Relapsed or refractory diffuse large B-cell lymphoma (DLBCL), as monotherapy after two or more prior lines of systemic therapy.
- Relapsed or refractory diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS), in combination with gemcitabine and oxaliplatin for patients who are ineligible for autologous stem cell transplant.
Background of the Safety Issue
Haemophagocytic lymphohistiocytosis (HLH), including fatal cases, has been reported with Columvi® in clinical trials and post-marketing experience. HLH is a severe hyperinflammatory syndrome driven by pathologic immune activation that may result in cytokine storm and life-threatening multiorgan damage.
HLH associated with T-cell-engaging therapies, also referred to as Immune Effector Cell-associated HLH-Like Syndrome (IEC-HS), may mimic severe cytokine release syndrome (CRS). However, HLH is typically distinguished by a delayed onset, rapidly rising ferritin levels, and differences in cytokine profile. Importantly, treatment recommendations for HLH differ from those for CRS.
Early recognition and prompt management are essential. In cases of suspected HLH, Columvi® should be interrupted, expert consultation sought, and treatment initiated in accordance with current institutional or expert consensus guidelines.
The benefit-risk profile of Columvi® in the approved indications remains favourable.
Regulatory Action
On 2 April 2026, NPRA approved a Direct Healthcare Professional Communication (DHPC) letter issued by Roche (Malaysia) Sdn. Bhd. to inform healthcare professionals of this safety issue. For further information, please contact your local salesperson for a copy of the DHPC. The product label for Columvi® will be updated to reflect the new important identified risk.
Advice for Health Care Professionals
- Be aware of the risk of HLH, including fatal cases, in patients treated with Columvi®.
- Consider HLH in the differential diagnosis of patients presenting with severe inflammatory symptoms, especially where features overlap with CRS, noting that HLH may present with delayed onset, distinct cytokine profile and markedly elevated serum ferritin.
- Report all suspected adverse events related to the use of glofitamab to the NPRA.
References
- Direct Healthcare Professional Communication (DHPC). Columvi® (Glofitamab), New Important Identified Risks of Haemophagocytic Lymphohistiocytosis. Roche (Malaysia) Sdn. Bhd.; 2026 April 2.