High-Dose Wegovy Shows Superior Weight Loss in Phase 3b Study
Novo Nordisk's high-dose formulation of Wegovy, an obesity drug, has shown promising results in a Phase 3b study. Participants receiving a 7.2 milligram dose of Wegovy, combined with lifestyle intervention, experienced an average weight loss of 20.7% over 72 weeks. This is compared to a 17.5% weight loss in those on the currently approved 2.4 milligram dose and a 2.4% loss in the placebo group. Notably, one-third of the participants on the high dose achieved more than 25% weight loss. Detailed findings are expected to be presented at a scientific meeting in 2025, with additional data from a second high-dose study anticipated in the coming months.
FDA Approves AstraZeneca's Calquence for First-Line Mantle Cell Lymphoma Treatment
The FDA has granted approval for AstraZeneca's Calquence (acalabrutinib) for the treatment of adults with previously untreated mantle cell lymphoma (MCL) who are ineligible for transplant. MCL, a rare and aggressive form of non-Hodgkin lymphoma, often leads to relapse. The approval was based on Phase 3 trial results showing that Calquence, when used alongside chemotherapy and Rituxan, reduced the risk of disease progression or death by 27% compared to chemoimmunotherapy alone. This marks Calquence as the first BTK inhibitor approved for first-line treatment of MCL.
Amgen's Lumakras Receives FDA Approval for Colorectal Cancer
Amgen's Lumakras (sotorasib) has received FDA approval for use in treating colorectal cancer in combination with Vectibix (panitumumab). This approval is specifically for patients whose tumors express the KRAS G12C mutation and who have previously undergone chemotherapy. The decision was supported by study data indicating that the combination therapy extended progression-free survival by approximately three-and-a-half months. Lumakras, which is also approved for non-small cell lung cancer, represents a significant advancement in targeted cancer therapy.
Atara Biotherapeutics Faces Setback with FDA Rejection of Ebvallo
Atara Biotherapeutics announced that the FDA has issued a complete response letter for its experimental drug, Ebvallo, intended for the treatment of post-transplant lymphoproliferative disease associated with Epstein-Barr virus. The rejection was due to issues at a third-party manufacturing facility, with no specific concerns raised regarding Ebvallo's manufacturing process, clinical safety, or efficacy. Atara, in partnership with Pierre Fabre Laboratories, is now exploring strategic options and seeking funding to address the FDA's concerns and resubmit the application for Ebvallo, an allogeneic cell therapy aimed at treating adults and children two years or older who have received at least one prior therapy for their condition.
