NORTH CHICAGO, Ill., May 19, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved EPKINLYTM (epcoritamab-bysp), as the first and only T-cell engaging bispecific antibody for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), including DLBCL arising from indolent lymphoma, and high-grade B–cell lymphoma (HGBL), after two or more lines of systemic therapies. EPKINLY is approved under the FDA's Accelerated Approval program based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. EPKINLY is being co-developed by AbbVie and Genmab as part of the companies' oncology collaboration.
NORTH CHICAGO, Ill., Dec. 11, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced data from multiple clinical trials evaluating epcoritamab (DuoBody®-CD3xCD20), an investigational subcutaneous bispecific antibody, alone or in combination for the treatment of patients with relapsed/refractory (R/R) follicular lymphoma (FL), previously untreated FL, R/R diffuse large B-cell lymphoma (DLBCL), as well as Richter's syndrome at the 64th American Society of Hematology (ASH) Annual Meeting.
NORTH CHICAGO, Ill., Dec. 10, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced new data from Cohort 3 of its Phase 2 REFINE study of investigational navitoclax in combination with ruxolitinib in JAK inhibitor-naïve patients with myelofibrosis (MF). The exploratory analysis suggests the combination of navitoclax and ruxolitinib led to reductions in bone marrow fibrosis (BMF) and variant allele frequency (VAF) for common genetic mutations found in individuals with myelofibrosis that may indicate potential disease modification.1 The findings were shared in an oral presentation (abstract #237) at the 64th American Society of Hematology Annual Meeting & Exposition (ASH).
NORTH CHICAGO, Ill., Dec. 10, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced new and updated data across clinical and real-world studies in chronic lymphocytic leukemia (CLL). Presentations featured during the 64th American Society of Hematology (ASH) Annual Meeting and Exposition will include two clinical trials investigating once daily, fixed-duration treatment with IMBRUVICA® (ibrutinib) plus VENCLEXTA®/VENCLYXTO® (venetoclax) (I+V) in adults with CLL and several analyses from real-word data evaluating front-line treatment in CLL.
- Nearly 65 abstracts, including 15 oral presentations on 7 investigational and approved medicines across 8 cancer types, to be presented at the American Society of Hemaotology (ASH) annual congress
NORTH CHICAGO, Ill., Oct. 28, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the European Medicines Agency (EMA) has validated a Marketing Authorization Application (MAA) for epcoritamab (DuoBody®-CD3xCD20), an investigational subcutaneous bispecific antibody, for the treatment of adult patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. Additionally, Genmab has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for epcoritamab for the treatment of adult patients with R/R large B-cell lymphoma (LBCL) after two or more lines of systemic therapy.
NORTH CHICAGO, Ill., Aug. 24, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) approved the use of IMBRUVICA® (ibrutinib) for the treatment of pediatric patients one year and older with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy.
- New insights uncover how patients and caregivers cope emotionally during phases of Chronic Lymphocytic Leukemia (CLL)
- The findings also show majority of HCPs view treating CLL patients as different from treating other cancers
- The emotional complexities of this slow-growing cancer point to patient and caregiver need for greater support from HCPs at time of diagnosis
– Epcoritamab shows clinically meaningful efficacy in challenging-to-treat, highly refractory LBCL patients
– Total patient population achieved overall response rate (ORR) of 63 percent and complete response (CR) of 39 percent; CAR T-naïve patients achieved 69 percent ORR and 42 percent CR; patients previously treated with CAR T achieved a 54 percent ORR and 34 percent CR
– Safety profile is consistent with previous findings observed
– Results were reported as part of a late-breaking oral presentation selected for the Presidential Symposium at EHA
Stay up to date on recent news, articles, and more by subscribing to email alerts for one or more of our news topics.
Receive alerts on new stories, articles, and more by subscribing to one or more RSS Feeds.
You must be logged in to view this item.
YOU ARE ABOUT TO LEAVE FOR A 3RD PARTY WEBSITE
The "Yes" link below will take you out of the AbbVie family of websites.
Links which take you out of the AbbVie worldwide websites are not under the control of AbbVie, and AbbVie is not responsible for the contents of any such site or any further links from such site. AbbVie is providing these links to you only as a convenience and the inclusion of any link does not imply endorsement of the linked site by AbbVie.
The Internet site that you have requested may not be optimized to your screen size.
Do you wish to leave this site?