Lunsumio (mosunetuzumab-axgb) FDA approval for treating relapsed or refractory follicular lymphoma (FL) in adults.

On December 22, 2022, the Food and Drug Administration (FDA) granted accelerated approval to Lunsumio (mosunetuzumab-axgb) for the treatment of adults with relapsed or refractory follicular lymphoma. This medicine is manufactured by the company known as Genentech, Inc. Lunsumio, is designated as an orphan medicinal product for the treatment of follicular lymphoma.

Lunsumio is a prescription medicine used to treat adults with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies. It was granted initial U.S. approval in 2022. The active substance in Lunsumio is mosunetuzumab. 

Lunsumio And Its Indication

• Lunsumio contains mosunetuzumab, an antibody used in the treatment of follicular lymphoma (FL), a type of blood cancer affecting B cells. 
• Lunsumio is administered to adults who have undergone at least two prior FL treatments without success or experiencing recurrence.

What Is Follicular Lymphoma? 

Follicular lymphoma (FL) is a type of slow-growing blood cancer that originates from certain white blood cells called B-lymphocytes. These abnormal cells don’t function properly and grow too quickly, affecting the bone marrow and lymph nodes. FL is a form of B-cell lymphoma, a category of non-Hodgkin lymphoma (NHL).

Symptoms Of Follicular Lymphoma

Common signs of FL include swollen lymph nodes in the neck, underarms, abdomen, or groin, along with fatigue, shortness of breath, night sweats, and weight loss. Many individuals diagnosed with FL may not display noticeable symptoms initially.

Mechanism of Action

Lunsumio contains mosunetuzumab, a monoclonal antibody that binds to specific targets on B cells, including cancerous ones, and T cells. This binding forms a bridge, prompting T cells to eliminate the cancerous B cells, controlling and preventing the spread of follicular lymphoma.

Dosage Information

Important Dosing Information:

  – Administer Lunsumio to well-hydrated patients.

  – Premedicate before each dose in Cycle 1 and Cycle 2.

  – Administer only as an intravenous infusion through a dedicated infusion line. Do not use an in-line filter to administer Lunsumio.

The recommended dosage for Lunsumio injection involves a specific cycle-based administration: 

• On Cycle 1, Day 1, a dose of 1 mg is advised, followed by 2 mg on Cycle 1, Day 8. 
• Notably, on Cycle 1, Day 15, a higher dose of 60 mg is recommended. 
• Subsequent cycles maintain a dose of 60 mg on Cycle 2, Day 1, and then a reduced but continued dose of 30 mg on Day 1 for Cycle 3 and beyond. 
• This structured dosing regimen is designed for the effective treatment of follicular lymphoma in adult patients who have undergone at least two prior treatments with inadequate response or recurrence.

Drug Interaction

LUNSUMIO’s interaction with CYP450 substrates may lead to increased exposure, especially after the first and second doses, and during cytokine release syndrome. Monitoring is essential for potential toxicity or altered substrate concentrations, with dosage adjustments as per prescribing information.

Warning And Precaution

• Neurologic Toxicity: Lunsumio carries the risk of severe neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS). Close monitoring for neurologic signs is vital, and adjustments or discontinuation may be necessary based on severity.

• Infections: Lunsumio may lead to serious or fatal infections, including opportunistic infections. Thorough monitoring for infection symptoms is crucial, and prompt treatment is required.

• Cytopenias: Regular monitoring of complete blood cell counts is advised during Lunsumio treatment to address cytopenias promptly.

• Tumor Flare: Lunsumio can induce significant tumor flare reactions. Close monitoring is recommended for patients at risk of tumor flare-related complications.

Pregnancy 

Due to its mechanism of action, Lunsumio has the potential to cause harm to the fetus if administered to pregnant women. It is recommended to inform pregnant women about the potential risk to the fetus. Additionally, females of reproductive potential should be advised to use effective contraception during Lunsumio treatment and for three months after the last dose.

Lactation 

It is not known whether Lunsumio is excreted in human milk or has any effects on the breastfed infant or milk production. A decision should be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

The safety and effectiveness of Lunsumio in pediatric patients have not been established.

Geriatric Use

No dosage adjustment is recommended based on age. However, geriatric patients may be more sensitive to the effects of Lunsumio.

Side Effects

Common adverse reactions (≥ 20%) with Lunsumio include cytokine release syndrome, fatigue, rash, pyrexia, and headache. The most frequent Grade 3 to 4 laboratory abnormalities (≥ 10%) involve decreased lymphocyte count, decreased phosphate, increased glucose, decreased neutrophil count, increased uric acid, decreased white blood cell count, decreased hemoglobin, and decreased platelets. 

Other Information

Lunsumio is associated with a boxed warning for cytokine release syndrome (CRS), including serious or life-threatening reactions. It is important to follow the dosing and administration recommendations carefully and monitor patients for adverse reactions during and after administration.

How Can I buy Lunsumio Online?

These days, purchasing Lunsumio online is a simple option, particularly for people in the US and Europe. You can contact other trustworthy companies that specialize in importing pharmaceuticals from these regions, or the SANSFRO team, to start this procedure.

Please contact our committed Patient Support Team at (91) 9315705373 or by email at help@sansfro.com for comprehensive information on the Lunsumio price in the Indian market and specifics on procurement. Our group is committed to giving the Indian market precise and up-to-date Lunsumio price information. Get in touch with our dependable services to guarantee a smooth experience obtaining this necessary medication.

Conclusion

Lunsumio is a novel treatment for adult patients with relapsed or refractory follicular lymphoma. It has been granted approval based on its mechanism of action and clinical trial data, and its use is associated with specific dosing and administration requirements, as well as potential risks and side effects. Healthcare providers should carefully review the full prescribing information for Lunsumio before initiating treatment in eligible patients. For more details contact the health care profession. 

Reference: 

1. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761263s000lbl.pdf
2. https://www.ema.europa.eu/en/documents/assessment-report/lunsumio-epar-public-assessment-report_en.pdf
3.  https://www.ema.europa.eu/en/medicines/human/EPAR/lunsumio