COLUMVI (glofitamab-gxbm)

COLUMVI (glofitamab-gxbm)

Diagnosis considered for coverage:

• Large B-cell Lymphoma: Indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy.
  • This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Coverage Criteria:

For diagnosis of lymphoma:

• Diagnosis of one of the following:
  • Relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS)
  • Large B-cell lymphoma (LBCL) arising from follicular lymphoma; AND
• Patient has had two or more lines of systemic therapy (e.g., chemotherapy); AND
• Patient will receive pretreatment with Gazyva (obinutuzumab).

Reauthorization Criteria:

For diagnosis of lymphoma:

• Patient does not show evidence of progressive disease while on therapy; AND
• Patient has not received more than 12 cycles of Columvi.

Dosing:

• DLBCL; LBCL:
  • Pretreat all patients with a single 1,000 mg dose of obinutuzumab administered as an intravenous infusion on Cycle 1 - Day 1; 7 days prior to initiation of COLUMVI to deplete the circulating and lymphoid tissue B cells. 
    • Administer the COLUMVI infusions intravenously in a healthcare setting with immediate access to medical support to manage CRS, including severe CRS.
  • COLUMVI dosing begins with a step-up dose schedule:
    • Cycle 1 – Day 8 (Step-up dose 1): 2.5 mg over 4 hrs.
    • Cycle 1 – Day 15 (Step-up dose 2): 10 mg over 4 hrs.
    • Cycle 2 – Day 1: 30 mg over 4 hrs.
    • Cycle 3 to 12 – Day 1: 30 mg over 2 hrs.
  • Each treatment cycle is 21 days long.

Coverage Duration:

• 1 year

Authorization is not covered for the following:

• The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:

• Black Box Warning: Cytokine Release Syndrome (CRS), including serious or fatal reactions, can occur in patients receiving COLUMVI. Premedicate before each dose, and initiate treatment with the COLUMVI step-up dosing schedule to reduce the risk of CRS. Withhold COLUMVI until CRS resolves or permanently discontinue based on severity.
• Non-Hodgkin’s lymphomas (NHLs) are a heterogeneous group of lymphoproliferative disorders that originate in B-lymphocytes, T-lymphocytes, or natural killer cells. Diffuse large B-cell lymphoma (DLBCL) is the most common subtype of large B-cell lymphoma (LBCL), and accounts for more than 30% of patients with NHL. Furthermore, some patients may undergo histologic transformation of indolent or other lymphomas (eg, follicular lymphoma [FL]) to DLBCL.
• DLBCL not otherwise specified (NOS) is defined by large-cell morphology, mature B-cell phenotype, and lack of criteria defining a specific LBCL entity. Lymphomas that are classified as DLBCL NOS are morphologically and molecularly heterogeneous.

Policy Updates:

• 11/14/2023 – New policy approved by WHA P&T Committee. (P&T 11/14/2023)

References:

1. Columvi Prescribing Information. Genentech, Inc. South San Francisco, CA. June 2023.
2. Food and Drug Administration. FDA press release: FDA grants accelerated approval to glofitamab-gxbm for selected relapsed or refractory large B-cell lymphomas. June 16, 2023(b). FDA Web site. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-glofitamab-gxbm-selected-relapsed-or-refractory-large-b-cell. Accessed July 18, 2023.
3. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology –B-Cell Lymphomas. V5.2023. NCCN Web site. https://www.nccn.org/professionals/physician_gls/pdf/b-cell.pdf. Accessed July 7, 2023.