Genmab

TIVDAK® Supplemental Biologics License Application Accepted for Priority Review by FDA for Patients with Recurrent or Metastatic Cervical Cancer

Retrieved on: 
Tuesday, January 9, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, Woman, Patient, Progression-free survival, Genmab, Pneumonitis, Peripheral neuropathy, Survival, Pfizer, ESMO, Bleeding, PFE, Food, Cervical cancer, Disease, PFS, Safety, Congress, Priority review, Toxicity, PDUFA, Inc., Pharmaceutical industry

The application has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) goal date of May 9, 2024.

Key Points: 
  • The application has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) goal date of May 9, 2024.
  • The safety profile of TIVDAK in innovaTV 301 was consistent with its known safety profile as presented in the U.S. prescribing information.
  • In October 2023, results from the innovaTV 301 study were presented during a Presidential Symposium at the European Society of Medical Oncology (ESMO) Congress.
  • The accelerated approval is based on tumor response and durability of response from the innovaTV 204 pivotal Phase 2 single-arm clinical trial evaluating TIVDAK as monotherapy in patients with previously treated recurrent or metastatic cervical cancer.

New Data for Bispecific Antibody Epcoritamab (DuoBody® CD3xCD20) Shows Strong, Durable Treatment Response for Patients with Difficult-To-Treat Relapsed/Refractory (R/R) Follicular Lymphoma (FL)

Retrieved on: 
Saturday, December 9, 2023
Fever, NYSE, Cytokine release syndrome, Injection site reaction, Food, European Medicines Agency, Type, Incidence, Lymphoid leukemia, ASH, CRS, Disease, Risk, Clinical trial, Hematology, Fatigue, EMA, Patient, European, BTD, Data analysis, FDA, AbbVie, Follicular lymphoma, COVID-19, Neutropenia, ORR, University of Paris, Diarrhea, Death, APHP, ABBV, Genmab, Pharmaceutical industry

NORTH CHICAGO, Ill., Dec. 9, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) and Genmab A/S (Nasdaq: GMAB) announced today that adult patients with relapsed/refractory (R/R) follicular lymphoma (FL) previously treated with two or more prior therapies experienced strong and durable responses with high overall response (ORR) and complete response (CR) rates when treated with epcoritamab (DuoBody® CD3xCD20), an investigational, subcutaneously administered T-cell engaging bispecific antibody. More than half of patients who responded to treatment in the study remained responsive to treatment at the time of data analysis (i.e., median duration of response was not reached). Data from the dose-expansion cohort of the Phase 1/2 EPCORE™ NHL-1 clinical trial are being shared during a poster presentation on Saturday, December 9 at 5:30 PM PT at the ASH congress in San Diego, California. Updated data from this study include an optimized, step-up dosing schedule showing reduced incidence and severity of cytokine release syndrome (CRS), a notable side effect from immune-engaging cancer treatments.

Key Points: 
  • More than half of patients who responded to treatment in the study remained responsive to treatment at the time of data analysis (i.e., median duration of response was not reached).
  • "These data at this year's ASH further build our confidence in epcoritamab's treatment potential as well as development for earlier patient treatment."
  • An estimated 85% and 74% of patients who experienced a CR remained responsive to treatment at 12 and 18 months, respectively.
  • TEAEs leading to treatment discontinuation occurred in 19% of patients, and death related to TEAEs occurred in 13 patients (10%).

Genmab Announces Financial Results for the First Nine Months of 2023

Retrieved on: 
Tuesday, November 7, 2023
Sale, BioNTech, Janssen, DKK, Novartis, Interim, USD, AbbVie, Patient, OS, Clothing, Pharmaceutical industry, Genmab, Health, Ofatumumab, Seagen

Revenue was DKK 11,796 million for the first nine months of 2023 compared to DKK 9,368 million for the first nine months of 2022.

Key Points: 
  • Revenue was DKK 11,796 million for the first nine months of 2023 compared to DKK 9,368 million for the first nine months of 2022.
  • Operating expenses were DKK 8,045 million in the first nine months of 2023 compared to DKK 5,676 million in the first nine months of 2022.
  • Operating profit was DKK 3,651 million in the first nine months of 2023 compared to DKK 3,692 million in the first nine months of 2022.
  • Net financial items resulted in income of DKK 1,060 million for the first nine months of 2023 compared to DKK 2,681 million in the first nine months of 2022.

TIVDAK® (tisotumab vedotin-tftv) Significantly Prolonged Overall Survival in Patients with Recurrent or Metastatic Cervical Cancer Compared with Chemotherapy in Global Phase 3 innovaTV 301 Trial

Retrieved on: 
Sunday, October 22, 2023
Biotechnology, Pharmaceutical, Health, Oncology, European Society for Medical Oncology, Cervical cancer, Genmab, ESMO, Congress, PFS, Hazard, HIV disease progression rates, Inc., Clinical trial, Network, Risk, European Society of Gynaecological Oncology, Progression-free survival, Patient, Death, Pharmaceutical industry

Data were presented during the Presidential Symposium at the European Society of Medical Oncology (ESMO) Congress 2023.

Key Points: 
  • Data were presented during the Presidential Symposium at the European Society of Medical Oncology (ESMO) Congress 2023.
  • The confirmed objective response rate (ORR) was also statistically significantly improved with TIVDAK (17.8%) compared with chemotherapy (5.2%); odds ratio: 4.0 [95% CI, 2.1-7.6], p
  • In innovaTV 301, treatment-related adverse events (TRAEs) occurring in patients with TIVDAK were generally low grade and manageable with supportive care and dose modifications.
  • “Recurrent or metastatic cervical cancer is a devastating disease,” said Roger Dansey, M.D., President of Research and Development and Chief Medical Officer at Seagen.

Genmab Announces Net Sales of DARZALEX® (daratumumab) for Third Quarter of 2023

Retrieved on: 
Tuesday, October 17, 2023
USD, Janssen, SC, Daratumumab, Johnson & Johnson, Music, Pharmaceutical industry, Genmab, Hyaluronidase

Genmab receives royalties on worldwide net sales from Janssen Biotech, Inc. (Janssen)

Key Points: 
  • Genmab receives royalties on worldwide net sales from Janssen Biotech, Inc. (Janssen)
    COPENHAGEN, Denmark; October 17, 2023 – Genmab A/S (Nasdaq: GMAB) announced today that worldwide net trade sales of DARZALEX® (daratumumab), including sales of the subcutaneous (SC) product (daratumumab and hyaluronidase-fihj, sold under the tradename DARZALEX FASPRO® in the U.S.), as reported by Johnson & Johnson were USD 2,499 million in the third quarter of 2023.
  • Net trade sales were USD 1,369 million in the U.S. and USD 1,130 million in the rest of the world.
  • Genmab receives royalties on the worldwide net sales of DARZALEX, both the intravenous and SC products, under the exclusive worldwide license to Janssen to develop, manufacture and commercialize daratumumab.

EPKINLY™ (epcoritamab) Approved by Japan Ministry of Health, Labour and Welfare as the First Bispecific Antibody to Treat Adults Patients with Certain Types of Relapsed or Refractory (R/R) Large B-Cell Lymphoma (LBCL)

Retrieved on: 
Monday, September 25, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, PMBCL, Neutropenia, DLBCL, Ministry of Health, Labour and Welfare, Prognosis, Appetite, Doctor of Philosophy, B-cell lymphoma, Rash, ORR, Lymphocytopenia, Cytokine release syndrome, MD, AbbVie, Patient, Thrombocytopenia, Safety, Pharmaceutical industry, Genmab

Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration.

Key Points: 
  • Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration.
  • Of 157 patients treated with EPKINLY, 130 (82.8 percent) experienced treatment related side effects.
  • The most common side effects (>15 percent) included cytokine release syndrome (49.7 percent), injection site reactions (19.7 percent), and neutropenia (17.8 percent).
  • Of 36 patients treated with EPKINLY, 36 (100 percent) experienced treatment related side effects.

Seagen and Genmab Announce TIVDAK® (tisotumab vedotin-tftv) Improved Overall Survival in Patients With Recurrent or Metastatic Cervical Cancer Compared With Chemotherapy Alone

Retrieved on: 
Monday, September 4, 2023
Science, Biotechnology, Research, Pharmaceutical, Oncology, General Health, Health, Clinical Trials, Inc., Histology, Survival, Food and Drug Administration, OS, Seagen, Research and development, Development, HIV disease progression rates, Cervical cancer, Patient, Neoplasm, Food, Safety, Pharmaceutical industry, Genmab

An Independent Data Monitoring Committee determined that OS crossed the pre-specified efficacy boundary at interim analysis.

Key Points: 
  • An Independent Data Monitoring Committee determined that OS crossed the pre-specified efficacy boundary at interim analysis.
  • The key secondary endpoints of investigator-assessed progression-free survival and objective response rate also demonstrated statistical significance.
  • The innovaTV 301 China extension study has been initiated and continues to enroll patients, in collaboration with Zai Lab Limited.
  • “These results provide hope for patients with recurrent or metastatic cervical cancer.”

Genmab Announces Financial Results for the First Half of 2023

Retrieved on: 
Thursday, August 3, 2023
BioNTech, Interim, DLBCL, Cancer, DKK, Janssen, USD, Sale, B-cell lymphoma, U.S. FDA, Novartis, Patient, AbbVie, Growth, FDA, Regulation of tobacco by the U.S. Food and Drug Administration, Food, Clothing, Pharmaceutical industry, Genmab, Ofatumumab

Revenue was DKK 7,052 million for the first six months of 2023 compared to DKK 5,281 million for the first six months of 2022.

Key Points: 
  • Revenue was DKK 7,052 million for the first six months of 2023 compared to DKK 5,281 million for the first six months of 2022.
  • Operating expenses were DKK 5,118 million in the first six months of 2023 compared to DKK 3,520 million in the first six months of 2022.
  • Operating profit was DKK 1,934 million in the first six months of 2023 compared to DKK 1,761 million in the first six months of 2022.
  • Net financial items resulted in income of DKK 75 million for the first six months of 2023 compared to DKK 1,340 million in the first six months of 2022.

Lymphoma Research Foundation to Honor Esteemed Lymphoma Physician Kara Kelly, MD at Annual Gala on September 28

Retrieved on: 
Wednesday, August 2, 2023
Lymphoma, SAB, University, Pediatrics, Therapy, Senior, Jacobs School of Medicine and Biomedical Sciences, Bone marrow, American Biographical Institute, John R. Oishei Children's Hospital, Children's Oncology Group, Cancer, Buffalo buffalo Buffalo buffalo buffalo buffalo Buffalo buffalo, Buffalo, Research, Roswell Park, Biomedical sciences, Young adult, Hodgkin, Waldemar, LRF, MD, Patient, Division, American Society of Pediatric Hematology/Oncology, Hospital, Leukemia, Health, Ziegfeld Theatre (1969), Pharmaceutical industry, Nursing, Genmab

NEW YORK, Aug. 2, 2023 /PRNewswire-PRWeb/ -- The Lymphoma Research Foundation (LRF), the nation's largest non-profit organization dedicated exclusively to funding innovative lymphoma research and serving the lymphoma community through a comprehensive series of education programs, outreach initiatives, and patient services, will host its 2023 Annual Gala on Thursday, September 28, at the Ziegfeld Ballroom in New York City.

Key Points: 
  • Genmab will be presented with the Lymphoma Research Foundation's Corporate Leadership Award for excellence in development of differentiated antibody therapeutics.
  • Honored at this year's gala will be LRF Scientific Advisory Board (SAB) member Kara Kelly, MD, who will recieve LRF's Distinguished Leadership Award.
  • "I am so incredibly honored to be receiving the Distinguished Leadership Award from the Lymphoma Research Foundation.'
  • We are proud to support the important work of the Lymphoma Research Foundation in achieving our shared goals for patients."

Genmab Updates 2023 Financial Guidance

Retrieved on: 
Thursday, July 27, 2023
Growth, DKK, USD, Pharmaceutical industry, Genmab

Genmab expects its 2023 revenue to be in the range of DKK 15,500 – 16,500 million, an increase to the previous guidance of DKK 14,600 – 16,100 million, driven by the continued strong growth of DARZALEX® net sales and higher total royalty revenues from DARZALEX and other marketed products.

Key Points: 
  • Genmab expects its 2023 revenue to be in the range of DKK 15,500 – 16,500 million, an increase to the previous guidance of DKK 14,600 – 16,100 million, driven by the continued strong growth of DARZALEX® net sales and higher total royalty revenues from DARZALEX and other marketed products.
  • DARZALEX royalties are based on Genmab’s revised estimate of DARZALEX 2023 net sales of USD 9.8 – 10.0 billion compared to Genmab’s previous estimate of USD 9.4 – 10.0 billion.
  • Genmab anticipates its 2023 operating expenses to be in the range of DKK 10,400 – 10,900 million, an increase to the previous guidance of DKK 9,800 – 10,600 million, primarily related to increased and accelerated investment for epcoritamab clinical trials and progression of other pipeline products.
  • Genmab now expects its 2023 operating profit to be in the range of DKK 4,500 – 6,000 million, compared to the previous guidance of DKK 3,900 – 6,200 million, driven primarily by the items described above.