Foot in door for first-in-class antibody-drug conjugate
Immunomedics (Nasdaq: IMMU) has at last won approval for the first Trop-2 targeting antibody-drug conjugate, Trodelvy (sacituzumab govitecan-hziy).
The option was given an accelerated approval for people with metastatic triple-negative breast cancer (mTNBC), in the third-line setting.
It hasn’t been a straight road to approval for the New Jersey, USA-based firm, with the US regulator earlier rejecting a bid for accelerated approval, on the basis of quality control problems, including a data integrity breach.
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