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BEERS, BELGIUM, Jan. 3, 2023 (GLOBE NEWSWIRE) — The Janssen Pharmaceutical Companies of Johnson & Johnson today submitted a Marketing Authorization Application (MAA) seeking approval for the treatment of tarquetamab to the European Medicines Agency (EMA) announced that it had been submitted to Number of patients with relapsed or refractory multiple myeloma (RRMM). Tarketamab is an off-the-shelf (ready-to-use) bispecific T-cell engager antibody in development that targets GPRC5D, a novel drug target present in some normal cells but overexpressed in myeloma cells. Targets both CD3 on T cells.1
“Despite progress, there remains a high unmet need for heavily pretreated multiple myeloma patients. is only 30%.” Chief Hematology, Janssen-Cilag Limited. “Innovative therapeutic approaches such as Tarquetamab that involve new cellular targets are important for improving patient outcomes. I am doing it.”
In November 2022, the EMA granted accelerated evaluation of tarquetamab. Expedited evaluation reduces the time it takes for MAA review and is awarded when a drug is of great public health and therapeutic innovation interest.2
This MAA evaluated the Phase 1/Phase 2, first-in-human MonumenTAL-1 trial of talketamab in patients with RRMM who had received at least 3 prior therapies (Phase 1: NCT03399799; Phase 2: NCT04634552 ) is supported by the data of3,Four,Five The first Phase 2 results of this trial were presented during the oral science session at the 2022 American Society of Hematology (ASH) Annual Meeting (Abstract #157).Five These data were featured as part of the ASH Press Briefing, ash vest This session will focus on the major scientific and clinical themes presented during the conference. Results from the Phase 1 portion of the MonumentTAL-1 trial recently New England Journal of Medicine.6
“As the scientific understanding of multiple myeloma advances, we are focused on advancing a portfolio of innovative therapies that address this complex disease and patient needs,” Janssen Research and Development, LLC. “Today’s filing in Europe marks another important milestone in our progress and ambition to transform the treatment of multiple myeloma.”
The EMA submission follows a Biologics License Application (BLA) filed with the U.S. Food and Drug Administration (FDA) in December 2022 seeking approval of talquetamab for the treatment of RRMM.
#ENDS#
About Tarquetamab
Tarketamab is a commercial (ready-to-use), investigational, bispecific T-cell engager antibody that targets both GPRC5D, a novel multiple myeloma target, and CD3 on T-cells.1,Five GPRC5D is highly expressed in multiple myeloma cells and CD3 is involved in T cell activation.1,7
Administered by subcutaneous injection, talquetamab is currently being evaluated in several monotherapy and combination trials.3,Four,8,9,Ten,11,12
In addition to being granted accelerated evaluation by the EMA in November 2022, tarketamab received Priority Medicine (PRIME) designation from the EMA in January 2021 and Breakthrough Therapy Designation from the US FDA in June 2022. received. August 2021 and his FDA in May 2021.
About multiple myeloma
Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells in the bone marrow.13,14 In multiple myeloma, these malignant plasma cells change and grow out of control.13 In Europe, more than 50,900 people were diagnosed with multiple myeloma in 2020, and more than 32,400 patients died.15 Some people with multiple myeloma are asymptomatic at first, but others develop common symptoms such as fractures, pain, low red blood cell count, fatigue, hypercalcemia, and kidney failure. increase.16
About The Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we are creating a future where disease is a thing of the past. We are the pharmaceutical company of Johnson & Johnson, working tirelessly to create a future for patients around the world by fighting disease with science, improving access with ingenuity, and healing despair from the heart. continue. We focus on the areas of medicine where we can make the biggest difference. Cardiovascular, metabolic, retina. immunology; infectious diseases and vaccines; neuroscience; oncology; and pulmonary hypertension.
For more information, please visit www.janssen.com/emea.follow me www.twitter.com/janssenEMEA for our latest news. Janssen Pharmaceutica NV, Janssen-Cilag Limited, and Janssen Research & Development, LLC are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
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Cautionary Note Regarding Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding product development and potential benefits and treatment impacts. tarquetamabReaders are cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. Underlying assumptions are inaccurate or known or unknown risks or uncertainties prove material ise. Actual results may differ materially from our expectations and projections. Janssen Pharmaceutica NV, Janssen–Shirag exclusive, Janssen Research and Development, LLC, Any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: the challenges and uncertainties inherent in product research and development; uncertainty of commercial success; manufacturing problems and delays; Competition, such as technological advances, new products, and patents issued by competitors. patent challenges; product efficacy or safety concerns leading to product recalls or regulatory action;behavior changeyour and spending patterns of purchasers of healthcare products and services. changes in applicable laws and regulations, including global healthcare reform; The trend towards containment of healthcare costs. A detailed list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January. February 2, 2022“Cautionary Note Regarding Forward-Looking Statements” and “Section 1A. Risk Factors” and After Johnson & Johnson Quarterly reports Form 10-Q others Notification to the stock exchange commission. Copies of these submissions are available online. www.sec.gov, www.jnj.com or upon request from Johnson & Johnson. Neither Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statements. as a result NEW INFORMATION OR FUTURE EVENTS OR DEVELOPMENTS.
References:
1 Pirarisetti K et al. T Cell Redirecting Bispecific G Protein-Coupled Receptor Class 5 Member D x CD3 Antibody
For the treatment of multiple myeloma. blood. 2020 Apr;135(15):1232-1243.
2 European Medicines Agency. accelerated evaluation. Available at https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/accelerated-assessment. Last accessed: December 2022.
3 ClinicalTrials.gov. A Dose Escalation Study of Tarquetamab in Participants With Relapsed or Refractory Multiple Myeloma (MonumenTAL-1). Available at https://clinicaltrials.gov/ct2/show/NCT03399799. Last accessed: December 2022.
Four ClinicalTrials.gov. A study of talquetamab in participants with relapsed or refractory multiple myeloma. Available at https://clinicaltrials.gov/ct2/show/NCT04634552. Last accessed: December 2022.
Five Charlie A et al. Tarquetamab, a G protein-coupled receptor family C group 5 member D x CD3 bispecific antibody in patients with relapsed/refractory multiple myeloma (RRMM): Phase 1/2 results from MonumenTAL-1. Oral presentation #157. American Society Hematology (ASH) Annual Congress 2022.
6 Charlie A et al. Tarketamab, a T cell-redirecting GPRC5D bispecific antibody against multiple myeloma. available:
https://www.nejm.org/doi/full/10.1056/NEJMoa2204591. Last accessed December 2022.
7 Cohen Y et al. GPRC5D is a promising marker to monitor tumor burden and target multiple myeloma cells. Hematology. 2013 Nov;18(6):348-51.
8 ClinicalTrials.gov. A study of the combination of talquetamab and teclitamab in participants with relapsed or refractory multiple myeloma (RedirecTT-1). Available at https://clinicaltrials.gov/ct2/show/NCT04586426. Last accessed: December 2022.
9 ClinicalTrials.gov. A study of talquetamab and teclitamab in combination with programmed cell death receptor-1 (PD-1) inhibitors for the treatment of participants with relapsed or refractory multiple myeloma (TRIMM-3). Available at https://clinicaltrials.gov/ct2/show/NCT05338775. Last accessed: December 2022.
Ten ClinicalTrials.gov. A study comparing tarketamab in combination with daratumumab or in combination with daratumumab and pomalidomide in combination with daratumumab in combination with pomalidomide and dexamethasone in participants with relapsed or refractory multiple myeloma (MonumentAL-3). Available at https://clinicaltrials.gov/ct2/show/NCT05455320. Last accessed: December 2022.
11 ClinicalTrials.gov. A study of a subcutaneous daratumma regimen in combination with a bispecific T cell-redirecting antibody for the treatment of participants with multiple myeloma. Available at https://clinicaltrials.gov/ct2/show/NCT04108195. Last accessed: December 2022.
12 ClinicalTrials.gov. A study of talquetamab and other anticancer therapies in participants with multiple myeloma (MonumentTAL-2). Available at https://clinicaltrials.gov/ct2/show/NCT05050097. Last accessed: December 2022.
13 American Society of Clinical Oncology. Multiple Myeloma: An Introduction. Available at https://www.cancer.net/cancer-types/multiple-myeloma/introduction. Last accessed: December 2022.
14 Abdi J et al. Drug resistance in multiple myeloma: latest findings and new concepts on molecular mechanisms Oncotarget. 2013;4(12):2186–2207.
15 GLOBOCAN 2020. Cancer Today Population Factsheets: European Region. Available at https://gco.iarc.fr/today/data/factsheets/populations/908-europe-fact-sheets.pdf. Last accessed: December 2022.
16 American Cancer Society. Multiple myeloma: early detection, diagnosis, staging. Available at https://www.cancer.org/content/dam/CRC/PDF/Public/8740.00.pdf. Last accessed: December 2022.
CP-355476
December 2022
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