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
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).
Johnson & Johnson is a step closer to realizing its vision of creating an all-oral, once daily, fixed-duration treatment regimen for chronic lymphocytic leukemia (CLL) patients. The Big Pharma’s strategy advanced last week when the European Medicines Agency’s drug review committee backed the candidate.
A not-so-funny thing happened to TG Therapeutics on its way to the accommodation review for its lead drug. The CEO revealed at an investment conference today that the FDA has slapped a hold over a segment of the R&D work it’s doing on the drug — a piece of the clinical plan that spurred some second looks after the hazard ratio made the drug look more dangerous than the comparator.
Among patients with previously untreated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), ibrutinib and venetoclax improved progression-free survival (PFS) compared with chlorambucil with obinutuzumab, according to research presented at the European Hematology Association (EHA) 2021 Virtual Congress.
- All-oral, once-daily, chemotherapy-free, fixed-duration ibrutinib plus venetoclax (I+V) combination met its primary endpoint of progression-free survival (PFS) as assessed by an independent review committee (IRC); I+V reduced the risk of disease progression or death by 78% compared to chlorambucil plus obinutuzumab (C+O)
he combination of ibrutinib and venetoclax may be effective for treating patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) due to the complementary mechanisms of action of the two targeted therapies. Ibrutinib mobilizes CLL cells from the lymph nodes and inhibits cancer cell proliferation while venetoclax kills any circulating cancer cells. The GLOW study is the first randomized clinical trial to investigate the efficacy and safety of ibrutinib + venetoclax (I+V) as a first-line fixed-duration oral treatment compared with chlorambucil + obinutuzumab (Clb+O) for untreated CLL/SLL. A total of 211 patients were recruited and randomized 1:1 with a median follow-up of 27.7 months.
TG Therapeutics’ experimental combination staved off cancer in patients with chronic lymphocytic leukemia (CLL), beating the control arm and teeing up an FDA filing by the end of the year.
After a spate of trial deaths forced AbbVie and Roche to halt trial enrollment for oncology med Venclexta in multiple myeloma, the future seemed dim for the drug’s expansion hopes in the disease. But now, after taking steps to increase safety, the drugmakers are getting another shot.
When AstraZeneca ended a late-stage trial for Calquence early after seeing promising results, the news boded well for the drug’s chances in previously treated chronic lymphocytic leukemia (CLL). Now, the drugmaker has unveiled the detailed data it plans to take before regulators later this year