LINVOSELTAMAB-GCPT INJ,SOLN
Clinical Criteria Summary
Document 595: Bispecific Antibody CRS and ICANS Neurotoxicity Supportive Care Guidance Jan 2026
Criteria for Blinatumomab
- Indication: Relapsed or Refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL)
- Pre-medication: Dexamethasone 16 mg IV
Criteria for Elranatamab
- Indication: Relapsed or Refractory Multiple Myeloma (BCMA target)
- REMS Requirement: Required
- Pre-medication: Dexamethasone 20mg PO/IV, Diphenhydramine 25mg PO, Acetaminophen 650mg PO
- Additional Supportive Meds: PJP prophylaxis, Antiviral prophylaxis
Criteria for Epcoritamab
- Indication: Relapsed or Refractory large B-cell lymphoma (CD20 target)
- Pre-medication: Dexamethasone 15mg PO/IV, Diphenhydramine 50mg PO/IV, Acetaminophen 650-1000mg PO
- Additional Supportive Meds: PJP prophylaxis, Antiviral prophylaxis
Criteria for Glofitamab
- Indication: Relapsed or Refractory large B-cell lymphoma (CD20 target)
- Pre-medication: Dexamethasone 20mg IV, Diphenhydramine 50mg PO/IV, Acetaminophen 500-1000 mg PO
- Additional Supportive Meds: Obinutuzumab day 1, Tumor lysis prophylaxis if at risk, Antiviral prophylaxis, PJP prophylaxis
Criteria for Mosunetuzumab
- Indication: Relapsed or Refractory follicular lymphoma (CD20 target)
- Pre-medication: Dexamethasone 20mg IV, Diphenhydramine 50-100 mg PO/IV, Acetaminophen 500-1000 mg
Criteria for Talquetamab
- Indication: Relapsed or Refractory multiple myeloma (GPRC5D target)
- REMS Requirement: Required
- Pre-medication: Dexamethasone 16mg PO/IV, Diphenhydramine 50mg PO, Acetaminophen 650-1000mg PO
- Additional Supportive Meds: Antiviral prophylaxis
- Keratotoxicity Management Criteria: Topical emollients for erythema/rash; saliva replacement therapy (VA National Formulary products include Artificial Saliva Oral Spray, Lozenge, Liquid and Gel) for oral toxicities
Criteria for Tebentafusp
- Indication: HLA-A*02:01 unresectable or metastatic uveal melanoma
- Pre-medication: None specified
Criteria for Teclistamab
- Indication: Relapsed or Refractory multiple myeloma (BCMA target)
- REMS Requirement: Required
- Pre-medication: Dexamethasone 16mg PO/IV, Diphenhydramine 50mg PO/IV, Acetaminophen 650-1000mg PO
- Additional Supportive Meds: Antiviral prophylaxis
Document 885: Linvoseltamab LYNOZYFIC Criteria Jul 2026final
Hematologic Parameters
- Exclusion: Baseline Absolute Neutrophil Count (ANC) < 1000/mm3 unless Duffy Null phenotype
- Exclusion: Baseline platelet count < 50,000/mm3
Organ Function (Renal & Hepatic)
- Exclusion: CrCl < 30 ml/min
- Exclusion: Moderate or severe hepatic impairment (Child-Pugh class B/C or NCI Organ Dysfunction Working Group Classification)
Infection & Immunologic Status
- Exclusion: Active or uncontrolled infection
- Exclusion: Known active central nervous system or meningeal involvement
Oncologic Disease State & Treatment History
- Inclusion: Relapsed or refractory multiple myeloma in a patient who has received at least four prior lines of therapy including a proteasome inhibitor, immunomodulatory agent and an anti-CD38 monoclonal antibody
Performance Status
- Inclusion: Eastern Cooperative Oncology Group Performance Status 0-1
Reproductive Health & Pregnancy/Lactation
- Exclusion: Pregnancy
- Exclusion: Lactating
- Additional Inclusion (Females who can become pregnant): Pregnancy should be excluded prior to receiving linvoseltamab
- Additional Inclusion (Females who can become pregnant): Counseling provided on potential risks vs benefits of treatment and the use of effective contraception during therapy and for 3 months after stopping treatment
Care Delivery & Administrative Requirements
- Inclusion: Myeloma care provided by VA or VA Community Care oncology provider certified with the LYNOZYFIC REMS program
- Inclusion: Goals of care and role of Palliative Care consult have been discussed and documented
Document 886: MON Linvoseltamab LYNOZYFIC Monograph Jul 2026 final
Indication & Patient Population
- Adult patients with relapsed or refractory multiple myeloma (RRMM)
Prior Therapy Requirements
- Received at least four prior lines of therapy
- Prior regimens must include a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody
Clinical Setting & Place in Therapy
- Utilized as an option for relapsed/refractory disease after ≥4 prior lines of therapy
- Listed as a preferred Category 2A option per NCCN MM guideline alongside other BCMA-directed therapies
Administration & Safety Management Requirements
- Requires a step-up dosing schedule to reduce the risk of Cytokine Release Syndrome (CRS)
- Administered via IV infusion
- Hospitalization is required after the first two step-up doses
- Available exclusively through the LYNOZYFIC REMS program due to CRS and neurotoxicity risks
Response-Based Clinical Monitoring
- Responders achieving ≥VGPR at or after Week 24 (after ≥17 doses of 200 mg) may transition to every 4-week dosing