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The FDA has now pushed its target decision date to October 23, 2025.
July 24, 2025 at 7:36 PM
The FDA has now pushed its target decision date to October 23, 2025.
This follows last week's FDA ODAC vote against the benefit-risk profile of the agent. The scheduled PDUFA target action date for belantamab mafodotin's BLA in the US was yesterday, July 23.
July 24, 2025 at 7:07 PM
This follows last week's FDA ODAC vote against the benefit-risk profile of the agent. The scheduled PDUFA target action date for belantamab mafodotin's BLA in the US was yesterday, July 23.
Despite CRL for combination, glofitamab monotherapy remains approved for R/R DLBCL (≥2 prior lines). STARGLO study showed 41% risk reduction in death for combination, published in The Lancet. Stay tuned for future developments. #Oncology #Hematology #ClinicalTrials
July 21, 2025 at 11:56 AM
Despite CRL for combination, glofitamab monotherapy remains approved for R/R DLBCL (≥2 prior lines). STARGLO study showed 41% risk reduction in death for combination, published in The Lancet. Stay tuned for future developments. #Oncology #Hematology #ClinicalTrials