MorphoSys Targets 2020 Tafasitamab Launch Following Good DLBCL Data
Morphosys says good L-MIND Phase II data back its plan to submit a US BLA to the US Food and Drug Administration by year-end, for a potential mid-2020 approval of tafasitamab.
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The antibody-drug conjugate yields a 48% overall and 24% complete response rate in a pivotal Phase II DLBCL study. The Swiss biotech hopes to compete with Polivy and is studying combo therapy with Imbruvica.
MorphoSys has chosen Incyte as its global partner for commercializing and further developing its lead asset, the Fc-engineered antibody tafasitamab that targets CD19.
Analysts tip Munich-based company for greatness, but it will need a big pharma partner to take on Roche's Polivy in competitive hemato-oncology market.