MONJUVI (tafasitamab-cxix)

MONJUVI (tafasitamab-cxix)

OFFICE ADMINISTRATION - INTRAVENOUS (IV)

Indications for Prior Authorization:

• MONJUVI is a CD19-directed cytolytic antibody indicated in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).

Patients must meet the following criteria:

Diffuse large B-cell lymphoma (DLBCL):

• Diagnosis of relapsed or refractory; AND
• Prescribed by or in collaboration with an oncologist; AND
• Used in combination with lenalidomide (Revlimid) for first 12 cycles; AND
• Patient is not eligible for autologous stem cell transplant (ASCT).

This Medication Is Not Approvable for the Following Condition(s):

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 Committee.

Dosing:

The recommended dosage of MONJUVI is 12 mg/kg as an IV infusion according to the following dosing schedule (adults):

• Cycle 1: Days 1, 4, 8, 15 and 22 of the 28-day cycle. 
• Cycles 2 and 3: Days 1, 8, 15 and 22 of each 28-day cycle. 
• Cycle 4 and beyond: Days 1 and 15 of each 28-day cycle.

Administer MONJUVI in combination with lenalidomide for a maximum of 12 cycles and then continue MONJUVI as monotherapy until disease progression or unacceptable toxicity.

Approval:

• Initial: 1 year.
• Reauthorization: 1 year when documented that patient does not show evidence of progressive disease while on therapy.

Additional Information:

• It is unclear if Monjuvi will have a negative impact on the efficacy of subsequent anti-CD19 CAR T-cell therapy.

Review History:

• 02/16/2021- New policy.

References:

• Campo E, Swerdlow SH, Harris NL, et al. The 2008 WHO classification of lymphoid neoplasms and beyond: evolving concepts and practical applications. Blood. 2011;117:5019-5032.
• ClinicalTrials.gov Web site. https://clinicaltrials.gov/ct2/home. Identifiers: NCT04134936, NCT02763319, NCT02639910. Accessed September 10, 2020. 
• Crump M, Neelapu SS, Farooq U, et al. Outcomes in refractory diffuse large B-cell lymphoma: results from the international SCHOLAR-1 study. Blood. 2017;130(16):1800-1808. Blood. 2018;131(5):587-588.
• Food and Drug Administration. Multi-discipline review: Monjuvi. 2019. FDA Web site. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761163Orig1s000MultidisciplineR.pdf. Accessed September 8, 2020.
• Food and Drug Administration. Press Release: FDA grants accelerated approval to tafasitamab-cxix for diffuse large B-cell lymphoma. July 31, 2020. FDA Web site. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-tafasitamab-cxix-diffuse-large-b-cell-lymphoma. Accessed September 8, 2020. 
• Jurczak W, Zinzani PL, Gaidano G, et al. Phase IIa study of the CD19 antibody MOR208 in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma. Ann Oncol. 2018;29(5):1266-1272.
• Monjuvi [package insert], Boston, MA: Morphosys US, Inc.; July 2020.
• National Comprehensive Cancer Network (NCCN). NCCN clinical practice guidelines in oncology – B-Cell Lymphomas, version 4.2020 – August 13, 2020. NCCN Web site. https://www.nccn.org/professionals/physician_gls/pdf/b-cell.pdf. Accessed September 8, 2020.
• Oken M, Creech R, Tormey D, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982;5(6):649-655.
• Salles G, Duell J, González Barca E, et al. Tafasitamab plus lenalidomide in relapsed or refractory diffuse large B-cell lymphoma (L-MIND): a multicentre, prospective, single-arm, phase 2 study. Lancet Oncol. 2020;21(7):978-988.
• Swerdlow SH, Campo E, Pileri SA, et al. The 2016 revision of the World Health Organization classification of lymphoid neoplasms. Blood. 2016;127(20):2375-90. doi: 10.1182/blood-2016-01-643569.