FDA approves ✔️ Tafasitamab-cxix for relapsed or refractory follicular lymphoma (FL)

On June 18, 2025, The FDA has approved tafasitamab-cxix (Monjuvi®) to be used in combination with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma (FL). More information regarding safety and efficacy trials are give at FDA.

Monjuvi® (Tafasitamab-cxix) Clinical insights🧑‍⚕️:

The clinical insights of Tafasitamab-cxix are given as follow:

What is Tafasitamab-cxix really is❓

Tafasitamab is a humanized, CD19-directed cytolytic monoclonal antibody developed for the treatment of B-cell related malignancies.
It is developed via rDNA technology in Chinese hamster ovary cells, and consists of an IgG1/2 hybrid Fc-domain which has been altered with 2 amino acid changes to enhance its cytotoxicity relative to non-engineered anti-CD19 antibodies.
The CD19 surface protein is extensively expressed on the surface of B-cells, whose function is to enhance B-cell receptor signalling. Its relative omnipresence throughout various stages of B-cell development, including pre-B and mature B-lymphocytes, as well as its presence in several B-cell malignancies (e.g. chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), diffuse large B-cell lymphoma (DLBCL)) has made it an important target in the treatment these B-cell malignancies.
Tafasatimab is intended to bind to and block the activity of the CD19 surface antigen, which ultimately lead to the lysis of B-cells (both healthy and malignant)

Available dosage form/route of Monjuvi® (Tafasitamab-cxix):

Solution: For intravenous 💉

(For injection: 200 mg of tafasitamab-cxix comes as lyophilized powder in single dose vial for reconstitution).

Recommended Dosage Tafasitamab-cxix :

The recommended tafasitamab-cxix dose is 12 mg/kg given as an intravenous infusion for a maximum of 12 cycles with lenalidomide and rituximab.
Refer to the prescribing information of Monjuvi® (Tafasitamab-cxix) for details regarding the treatment regime.
⚠️Tafasitamab-cxix is neither indicated nor recommended for patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials.

Adverse drug reaction Tafasitamab-cxix:

Most common reported ADRs that occur as a result of the administration of tafasitamab-cxix are as follow:

💉Infusion-related reactions
🩸Myelosuppresion
🤒Opportunistic infection

These adverse drug reactions occur in varying degrees in different patients. For reading mor about the ADRs please check the prescribing information of Monjuvi® (Tafasitamab-cxix).

Lenalidomide :

lenalidomide is a thalidomide derivative having antineoplastic, anti-angiogenic, and anti-inflammatory properties, used to treat multiple myeloma (in combination with other drugs) and anemia in low to moderate risk myelodysplastic syndrome.

Lenalidomide is somehow safer and potent than thalidomide, having less adverse effects and drug related toxicities.
Due to high potential of teratogenicity, pregnancy 🫄🏻 must be excluded before the initiation of treatment and patients must register in the lenalidomide Risk Evaluation and Mitigation Strategy (REMS) program to confirm contraception adherence.
Lenalidomide in combination with rituximab has been used for the treatment of adult patients with previously treated follicular lymphoma (FL).

Follicular Lymphoma:

Follicular lymphoma is a type of non-Hodgkin lymphoma (NHL). NHL is a type of blood cancer that affects white blood cells (WBCs) also known as lymphocytes.

It is also called as the cancer of the lymphatic system- a system consisting of tubes that carry a colourless liquid called lymph. Lymph consists of a huge number of lymphocytes which fight infection. This liquid circulates around the body tissues

Follicular lymphoma (FL) grows when the body makes abnormal B lymphocytes (B-Cells) which is the reason why FL is called as B cell lymphoma. The abnormal lymphocytes build up in the lymph nodes or other body organs causing various symptoms such as one or more painless swelling in the arms, neck or groins along with other symptoms like extreme sweating at nights, losing a lot of weight and high temperature without any reason.

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REFERENCES:

U.S. Food and Drug Administration. (2025, June 18). FDA approves tafasitamab-cxix for relapsed or refractory follicular lymphoma. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tafasitamab-cxix-relapsed-or-refractory-follicular-lymphoma?utm_medium=email&utm_source=govdelivery

U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA-approved drug products. Retrieved June 20, 2025, from https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process

DrugBank. (n.d.). Tazemetostat. DrugBank Online. Retrieved June 20, 2025, from https://go.drugbank.com/drugs/DB15044

DrugBank. (n.d.). Lenalidomide. DrugBank Online. Retrieved June 20, 2025, from https://go.drugbank.com/drugs/DB00480

Cancer Research UK. (n.d.). Follicular lymphoma. Retrieved June 20, 2025, from https://www.cancerresearchuk.org/about-cancer/non-hodgkin-lymphoma/types/follicular-lymphoma

Disclaimer: Information provided from the FDA Drugs@FDA database is for general informational purposes only and may be updated or changed by the FDA at any time. Always refer to official labeling and consult a healthcare professional for medical advice.