All articles tagged with #daiichi sankyo
Merck and Daiichi Sankyo voluntarily withdrew their accelerated approval application for the antibody-drug conjugate ifinatamab deruxtecan (I-DXd) in small cell lung cancer after the FDA deemed the data insufficient. This setback delays revenue from a $4 billion partnership and impacts competitors like Amgen and GSK.
The FDA has approved AstraZeneca and Daiichi Sankyo's drug Enhertu, in combination with Roche's Perjeta, as a first-line treatment for advanced HER2-positive breast cancer, based on a study showing improved progression-free survival and tumor response.
The Phase 2 IDeate-Lung01 trial showed that the drug ifinatamab deruxtecan achieved a 48.2% objective response rate in previously treated extensive-stage small cell lung cancer patients, with promising safety and efficacy data supporting further regulatory discussions.
Daiichi Sankyo and Merck's investigational drug ifinatamab deruxtecan has received FDA Breakthrough Therapy Designation for treating pretreated extensive-stage small cell lung cancer, based on promising clinical trial data, aiming to accelerate its development and approval.
Merck and Daiichi Sankyo have voluntarily withdrawn their BLA for HER3-DXd, a drug for NSCLC, after phase 3 trial results failed to meet survival endpoints and discussions with the FDA. Despite previous promising data, the drug's development faces setbacks, but the companies remain committed to ongoing research across multiple cancer types.
Merck has entered into a partnership with Daiichi Sankyo, committing $4 billion upfront, to co-develop and co-commercialize three antibody-drug conjugates (ADCs) from Daiichi's DXd platform. The ADCs target HER3, B7-H3, and CDH6, with the most advanced program set for a BLA filing by the end of March 2024. This partnership adds momentum to the growing ADC space, which has seen blockbuster revenue, data readouts, and increased M&A activity.
Merck has signed a $5.5 billion deal with Daiichi Sankyo to jointly develop three candidate cancer drugs, potentially worth up to $22 billion for the Japanese firm. The drugs belong to the class of antibody drug conjugates (ADC) and are designed to target cancer cells while minimizing damage to healthy cells. Daiichi Sankyo aims to generate at least $6 billion in revenue from its oncology business by 2026. The collaboration will expand the reach of the drugs and raise expectations for Daiichi Sankyo's oncology drug pipeline. Merck will pay $4 billion upfront and up to $16.5 billion in contingent payments based on future sales milestones.
Gilead and AstraZeneca/Daiichi Sankyo have presented preliminary mid-stage data on their rival TROP2 antibody-drug conjugates (ADCs) combined with immune checkpoint inhibitors in non-small cell lung cancer. While Gilead noticed a slightly higher response rate, analysts consider the results to be broadly similar. Both ADCs target the TROP2 receptor and have shown promise in breast cancer and NSCLC, with AstraZeneca's Dato-DXd in Phase III and Gilead's Trodelvy already approved for certain forms of breast cancer and bladder cancer.
The FDA has approved Daiichi Sankyo's Vanflyta (quizartinib) as a first-line treatment option for patients with FLT3-ITD-positive acute myeloid leukemia (AML). The drug can be used in combination with chemotherapy and as a maintenance monotherapy after initial treatment. A companion diagnostic has also been approved to detect the mutation.