ELRANATAMAB-BCMM INJ,SOLN

Clinical Criteria Summary

⇄ This criteria document covers 9 drugs .

See all drugs in this document

Indication: Relapsed or Refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL)
Pre-medication: Dexamethasone 16 mg IV

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

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

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

Indication: Relapsed or Refractory follicular lymphoma (CD20 target)
Pre-medication: Dexamethasone 20mg IV, Diphenhydramine 50-100 mg PO/IV, Acetaminophen 500-1000 mg

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

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

Relapsed or refractory multiple myeloma in a patient who has received at least four prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody
Oncologic care provided by a VA or VA Community Care oncology provider certified with the ELREXFIO REMS Program
Goals of care and role of Palliative Care consult discussed and documented
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2
Hospitalization required due to risk of Cytokine Release Syndrome: 48 hours after step-up dose #1 and 24 hours after step-up dose #2

For patients who can become pregnant or have partners who can become pregnant: counseling provided on potential risks vs. benefits of treatment and use of effective contraception during therapy and for four months after stopping treatment

Adults with relapsed or refractory multiple myeloma
Accelerated approval contingent upon clinical benefit verified in a confirmatory trial

Received at least four prior lines of therapy (LOT)
Prior regimens must include a proteasome inhibitor, an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody
Refractory to at least one proteasome inhibitor, at least one IMiD, and at least one anti-CD38 monoclonal antibody
May be used in patients with prior BCMA-directed therapy exposure (noted to have lower ORR in this population)

Injectable for subcutaneous administration
Step-up dosing: Day 1: 12 mg SQ; Day 4: 32 mg SQ; Day 8: 76 mg SQ (first full dose)
Administer weekly through week 24 following step-up
After 6 cycles, if partial response or better at 6 months and maintained for > 2 months, switch to dosing every 2 weeks until disease progression or unacceptable toxicity

Hospitalization recommended for the first two doses (step-up phase)
REMS program required
Monitor for cytokine release syndrome (CRS) and neurotoxicity including ICANS
Manage risks of infections, neutropenia, hepatotoxicity, and embryo-fetal toxicity

NCCN: Preferred bispecific antibody after > 4 LOT (category 2A)
VA Multiple Myeloma pathway: Listed as preferred for RRMM s/p > 4 LOT
Provides an option for patients with limited access to CAR T-cell therapy due to specialized centers or manufacturing issues