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Drug updates

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FDA fast track designation LBL-034

FDA fast track designation LBL-034

🚨NEWS🚨 @US_FDA grants fast track designation to LBL-034, an investigational GPRC5D/CD3 BiTE, for patients with R/R #MultipleMyeloma, supported by phase I/II dose-escalation data, including an ORR of 70.9%. Read more: https://loom.ly/Mfm1SIs

Important announcement

🚨NEWS🚨 @US_FDA approves SC daratumumab + VRd for the treatment of adults with ND #MultipleMyeloma ineligible for auto-HSCT, based on phase III CEPHEUS results. Read more: https://loom.ly/ih2NkUE

Important announcement

🚨NEWS🚨 @US_FDA grants fast track designation to IBI3003, a GPRC5D/BCMA/CD3-directed trispecific antibody, for the treatment of patients with relapsed/refractory #MultipleMyeloma and ≥4 prior LoT. Read more: https://loom.ly/awWuvXQ

Important announcement

🚨NEWS🚨 @US_FDA issues draft guidance on the potential use of MRD and CR in clinical trials to support accelerated approval of drugs to treat #MultipleMyeloma. Read more: https://loom.ly/l5-45Ro