DGAP-News: MorphoSys AG / Key word(s): Miscellaneous
National Comprehensive Cancer Network(R) Updates Designation of Monjuvi(R) (tafasitamab-cxix) to Preferred Regimen in its Clinical Practice Guidelines in Oncology for B-cell Lymphomas
BOSTON, Mass., USA - March 15, 2022 - MorphoSys U.S. Inc., a fully owned subsidiary of MorphoSys AG (FSE: MOR; NASDAQ: MOR), announced today that the National Comprehensive Cancer Network(R) (NCCN) Clinical Practice Guidelines (NCCN Guidelines(R)) in Oncology for B-cell Lymphomas have been updated, and the designation for Monjuvi(R) (tafasitamab-cxix) in combination with lenalidomide is now a Preferred Regimen for second-line therapy in patients with Diffuse Large B-cell Lymphoma (DLBCL) who are not candidates for transplant.
"Updates to NCCN Guidelines are made periodically when additional efficacy and safety data are available, providing current information on the use of cancer therapies," said Joe Horvat, U.S. General Manager, MorphoSys. "Monjuvi is a targeted immunotherapy that addresses an immediate medical need for certain adult patients living with Diffuse Large B-cell Lymphoma. We are gratified the NCCN panel acknowledged the additional data submitted for Monjuvi and updated the designation of Monjuvi in combination with lenalidomide to a Preferred Regimen in its Clinical Practice Guidelines in Oncology."
In July 2020, the U.S. Food and Drug Administration (FDA) approved Monjuvi in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate (ORR) from the one-year primary analysis of the L-MIND study. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). In the U.S., Monjuvi is the only approved second-line targeted immunotherapy for this patient population.
The NCCN is a not-for-profit alliance of 30 leading cancer centers devoted to patient care, research, and education. The intent of the NCCN Guidelines is to assist in the decision-making process of individuals involved in cancer care - including physicians, nurses, pharmacists, payers, patients, and their families - with the ultimate goal of improving patient care and outcomes. The updated NCCN Guidelines are available at www.nccn.org.
NCCN(R) and the NCCN Guidelines(R) are registered trademarks of National Comprehensive Cancer Network.
About Diffuse Large B-cell Lymphoma (DLBCL)
About Monjuvi (tafasitamab-cxix)
In the United States, Monjuvi (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low-grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
In Europe, Minjuvi(R) (tafasitamab) received conditional marketing authorization in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).
Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials.
Monjuvi and Minjuvi are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi in the U.S., and marketed by Incyte under the brand name Minjuvi in the EU.
XmAb(R) is a registered trademark of Xencor, Inc.
Important Safety Information
What are the possible side effects of MONJUVI?
- Infusion reactions. Your healthcare provider will monitor you for infusion reactions during your infusion of MONJUVI. Tell your healthcare provider right away if you get fever, chills, rash, flushing, headache, or shortness of breath during an infusion of MONJUVI.
- Low blood cell counts (platelets, red blood cells, and white blood cells). Low blood cell counts are common with MONJUVI, but can also be serious or severe. Your healthcare provider will monitor your blood counts during treatment with MONJUVI. Tell your healthcare provider right away if you get a fever of 100.4ºF (38ºC) or above, or any bruising or bleeding.
- Infections. Serious infections, including infections that can cause death, have happened in people during treatments with MONJUVI and after the last dose. Tell your healthcare provider right away if you get a fever of 100.4ºF (38ºC) or above, or develop any signs and symptoms of an infection.
The most common side effects of MONJUVI include:
- Feeling tired or weak
- Swelling of lower legs or hands
- Respiratory tract infection
- Decreased appetite
These are not all the possible side effects of MONJUVI.
Before you receive MONJUVI, tell your healthcare provider about all your medical conditions, including if you
- Have an active infection or have had one recently.
- Are pregnant or plan to become pregnant. MONJUVI may harm your unborn baby. You should not become pregnant during treatment with MONJUVI. Do not receive treatment with MONJUVI in combination with lenalidomide if you are pregnant because lenalidomide can cause birth defects and death of your unborn baby.
o You should use an effective method of birth control (contraception) during treatment and for at least 3 months after your final dose of MONJUVI.
o Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with MONJUVI.
- Are breastfeeding or plan to breastfeed. It is not known if MONJUVI passes into your breastmilk. Do not breastfeed during treatment for at least 3 months after your last dose of MONJUVI.
You should also read the lenalidomide Medication Guide for important information about pregnancy, contraception, and blood and sperm donation.
Please see the full Prescribing Information for Monjuvi, including Patient Information, for additional Important Safety Information.
MorphoSys Forward-looking Statements
1. Sarkozy C, et al. Management of relapsed/refractory DLBCL. Best Practice Research & Clinical Haematology. 2018 31:209-16. doi.org/10.1016/j.beha.2018.07.014.
2. Skrabek P, et al. Emerging therapies for the treatment of relapsed or refractory diffuse large B cell lymphoma. Current Oncology. 2019 26(4): 253-265. doi.org/10.3747/co.26.5421.
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