March 7 (Reuters) - The U.S. Food and Drug Administration has granted accelerated approval for the expanded use of BeiGene's (6160.HK), opens new tab combination drug to treat certain patients with a type of blood cancer, the health regulator said on Thursday.
SAN FRANCISCO, Dec. 11, 2023 /PRNewswire/ -- Nektar Therapeutics (NASDAQ:NKTR) announced that collaborators from the Cairo Laboratory at New York Medical College presented a poster highlighting new preclinical data on NKTR-255 at the 65th American Society of Hematology (ASH) Annual Meeting demonstrating that NKTR-255 significantly enhanced the cytotoxicity of expanded Natural Killer (NK) cells when combined with obinutuzumab against rituximab-resistant BL cells and significantly improved the survival of mice xenografted with Raji-4RH compared to controls.
Roche pulled its marketing authorization application with the European Medicines Agency (EMA) earlier this month to expand the label for its cancer medicine Gazyvaro, because the submitted data didn’t allow the Committee for Medicinal Products for Human Use (CHMP) to “conclude on a positive benefit/risk profile” for the drug.
The addition of zanubrutinib (Brukinsa) to obinutuzumab (Gazyva) produced superior clinical activity, prolonged survival, and had a favorable toxicity profile compared with obinutuzumab alone in heavily pretreated patients with relapsed/refractory follicular lymphoma, according to updated findings from the phase 2 ROSEWOOD trial (NCT03332017) presented at the 17th Annual International Conference on Malignant Lymphoma (ICML).1
The combination of venetoclax (Venclexta), atezolizumab (Tecentriq), and obinutuzumab (Gazyva) elicited responses and prolonged time progression, in patients with chronic lymphocytic leukemia with Richter transformation, according to data from the phase 2 MOLTO trial (NCT04082897) presented at the 17th Annual International Conference on Malignant Lymphoma.1
Fixed-duration therapy with venetoclax (Venclexta) plus obinutuzumab (Gazyva) led to 60% reduction in the risk of progression or death compared with chlorambucil plus obinutuzumab, with benefit seen regardless of TP53 or IGHV mutation status, in previously untreated patients with chronic lymphocytic leukemia (CLL), according to 6-year findings from the phase 3 CLL14 trial (NCT02242942).1
The combination of ibrutinib (Imbruvica), obinutuzumab (Gazyva), and venetoclax (Venclexta) was associated with prolonged survival in patients with newly diagnosed or relapsed/refractory mantle cell lymphoma (MCL), according to long-term follow-up data from the phase 1/2 OAsIs trial (NCT02558816) presented at the 2023 EHA Congress.1
Chugai Pharmaceutical Co., Ltd. and Nippon Shinyaku Co., Ltd. announced that Chugai obtained regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for an anti-cancer agent/humanized anti-CD20 monoclonal antibody Gazyva Intravenous Infusion 1000 mg [generic name: obinutuzumab (genetical recombination)] for an additional indication of CD20-positive chronic lymphocytic leukaemia (including small lymphocytic lymphoma).
Genentech's Gazyva (obinutuzumab) Receives BLA Approval in the U.S.
Genentech`s Gazyva (obinutuzumab) Receives Supplemental Approval in U.S.