Epkinly (Epcoritamab): FDA Approved Bispecific Antibody DLBCL

Introduction

Epkinly (epcoritamab) is a novel bispecific CD20-directed CD3 T-cell engager indicated for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy. This innovative therapy has received accelerated approval from the FDA, marking a significant advancement in the treatment of these challenging malignancies.

FDA Approval

On May 19, 2023, the FDA granted accelerated approval to epcoritamab-bysp (brand name Epkinly) for the treatment of relapsed or refractory DLBCL and high-grade B-cell lymphoma after multiple lines of systemic therapy. This approval provides a new treatment option for patients facing these difficult-to-treat cancers.

Manufacturer Details

Epkinly is manufactured by a pharmaceutical company called Genmab US, Inc. Epkinly is available as an injectable formulation for subcutaneous use. The medication is supplied as a sterile, lyophilized powder for reconstitution, and each vial contains the active ingredient epcoritamab.

What Is DLBCL?

Relapsed or refractory diffuse large B-cell lymphoma (DLBCL) occurs when the cancer returns after initial treatment or does not respond to the initial therapy. DLBCL, a type of non-Hodgkin lymphoma, originates in the lymphatic system. Dealing with relapsed or refractory DLBCL presents challenges, prompting the exploration of alternative treatment approaches, including novel therapies or participation in clinical trials, to address the cancer’s resistance to standard treatments.

Mechanism of Action

Epkinly is a bispecific CD20-directed CD3 T-cell engager designed to engage the immune system in targeting CD20-expressing B cells. By redirecting T cells to the tumor, Epkinly activates the patient’s immune response against cancer cells, potentially leading to tumor cell lysis and elimination.

Dosage Information and Mode of Administration

The recommended dosage and administration of Epkinly injection are based on the patient’s clinical status and should be determined by a physician. The medication is administered via subcutaneous injection, and the dosing regimen may involve a step-up dosing schedule to reduce the incidence and severity of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).

After receiving the Cycle 1 Day 15 dose of 48 mg, patients must undergo a 24-hour hospitalization. Before administration, follow the recommended premedications and prophylaxis guidelines. Epkinly dosages of 0.16 mg and 0.8 mg need to be diluted prior to administration. The product is offered in two dosage forms and strengths: a 4 mg/0.8 mL single-dose vial, requiring dilution before use, and a 48 mg/0.8 mL single-dose vial.

Warning And Precaution

• Epkinly treatment may cause cytokine release syndrome (CRS), a potentially serious condition. Initiate treatment with a step-up dosing schedule to reduce CRS incidence and severity. 
• If CRS occurs, withhold Epkinly until it resolves, considering permanent discontinuation based on severity. Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), infections, and cytopenias are potential risks. 
• Monitor for ICANS, signs of infection, and cytopenias, adjusting treatment accordingly. Epkinly may cause embryo-fetal toxicity, requiring females of reproductive potential to use effective contraception.

Usage in Specific Populations

• Pregnancy: There is limited data on the use of Epkinly in pregnant individuals. Healthcare providers should carefully consider the potential risks and benefits before prescribing Epkinly to pregnant patients.
• Lactation: The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Epkinly and any potential adverse effects on the breastfed infant.
• Pediatric and Geriatric Populations: The safety and effectiveness of Epkinly in pediatric and geriatric populations have yet to be established, and its use in these populations is not recommended.

Drug Interactions

Epkinly may have the potential to interact with other drugs, and healthcare providers should assess potential drug-drug interactions before prescribing Epkinly to patients.

Side Effects

Common adverse reactions associated with Epkinly treatment may include cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). Other potential side effects and adverse reactions should be carefully monitored and managed by healthcare professionals.

Conclusion

Epkinly represents a significant advancement in the treatment of relapsed or refractory DLBCL and high-grade B-cell lymphoma, offering a targeted therapeutic option for patients facing these challenging malignancies. Its unique mechanism of action, FDA approval, and potential impact on patient outcomes underscore the importance of this innovative therapy in the field of oncology. Healthcare providers should consider the specific indications, dosing, administration, and potential adverse effects of Epkinly when prescribing this medication to eligible patients.

FAQ: 

1. What are the common side effects of Epkinly?

The most common side effects of Epkinly may include CRS, tiredness, muscle and bone pain, injection site reactions, fever, stomach-area (abdominal) pain, nausea, and diarrhea. These are not all the possible side effects, and patients should consult their healthcare provider for a comprehensive understanding of potential adverse reactions and their management

2. Can Epkinly be used in pediatric and geriatric populations?

The safety and effectiveness of Epkinly in pediatric and geriatric populations have not been established, and its use in these populations is not recommended. Epkinly is approved for use in adult patients with certain types of diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma that have relapsed or not responded to previous treatment.

3. How to store Epkinly?

Keep Epkinly refrigerated at temperatures between 2°C to 8°C (36°F to 46°F). Store it in the original carton to shield it from light. Avoid freezing the medication, and do not shake it.

4. How to Buy Epkinly Online?

If you’re looking to purchase Epkinly online, consider reaching out to SANSFRO or other pharmaceutical procurement firms that specialize in importing medicines from the US and Europe. For detailed and India-specific information, contact the dedicated Patient Support Team at (+91) 9315705373 or help@sansfro.com.

5. What is the Epkinly price?

Epkinly price is influenced by various factors and product specifications. For accurate and up-to-date information on the Epkinly price in India, please get in touch with our Patient Support Team at (+91) 93157 05373 or via email at help@sansfro.com. Our team will provide you with the latest and precise details regarding the cost of Epkinly.

  Reference:

1. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761324s000lbl.pdf 
2. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761324s000lbl.pdf 
3.  https://www.fda.gov/media/155050/download 
4.  https://www.mepsevii.com/hcp/dosing-administration/storage/ 
5.  https://www.ultragenyx.com/medicines/mepsevii-full-prescribing-information/