Ifinatamab Deruxtecan Granted Breakthrough Therapy Designation by U.S. FDA for Patients with Pretreated Extensive-Stage Small Cell Lung Cancer
BASKING RIDGE, N.J. & RAHWAY, N.J.--(BUSINESS WIRE)--Ifinatamab deruxtecan (I-DXd) has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with extensive-stage small cell lung cancer with disease progression on or after platinum-based chemotherapy. Ifinatamab deruxtecan is a specifically engineered, potential first-in-class B7-H3 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568)
Related Questions
How will the Breakthrough Therapy Designation affect Ifinatamab deruxtecan's expected FDA approval timeline and market valuation of Daiichi Sankyo (DSKY)?
What is the potential market size and competitive landscape for B7‑H3 directed ADCs in extensive‑stage small cell lung cancer, and how might this influence Daiichi Sankyo's revenue forecasts?
What are the risks and upside scenarios surrounding upcoming clinical trial data or regulatory milestones for I‑DXd that could drive significant price volatility?