As­traZeneca's En­her­tu gets BTD for breast can­cer; Centes­sa nabs $300M loan

The FDA has grant­ed break­through des­ig­na­tion to As­traZeneca’s and Dai­ichi Sankyo’s HER2 ADC En­her­tu, the com­pa­nies joint­ly an­nounced to­day.

The BTD is for the treat­ment of adult pa­tients with un­re­sectable or metasta­t­ic HER2 pos­i­tive breast can­cer who have re­ceived one or more pri­or an­ti-HER2-based reg­i­mens.

Break­through ther­a­py des­ig­na­tion was based on da­ta from the DES­TINY-Breast03 piv­otal tri­al at #ES­MO21 just last month, which showed a 72% re­duc­tion com­pared to Roche’s ADC Kad­cy­la in the risk of dis­ease pro­gres­sion or death in pa­tients with HER2 pos­i­tive un­re­sectable and/or metasta­t­ic breast can­cer pre­vi­ous­ly treat­ed with trastuzum­ab and a tax­ane.

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