Theratechnologies Inc T.TH

RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:My opinion

[qwerty22]

Enhurtu. Must be putting pressure on all those breast cancer only drug developers. Hopefully we get breast+another.

"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.

“This is an im­por­tant step in bring­ing En­her­tu as a po­ten­tial new op­tion in ear­li­er lines of treat­ment for HER2 pos­i­tive metasta­t­ic breast can­cer, giv­en the ur­gent need to im­prove out­comes,” said As­traZeneca EVP of on­col­o­gy R&D Su­san Gal­braith in a state­ment.

Pre­vi­ous BTDs for the drug were in late-line HER2 pos­i­tive metasta­t­ic breast can­cer in 2017 and HER2 mu­tant metasta­t­ic non-small cell lung can­cer (NSCLC) and HER2 pos­i­tive metasta­t­ic gas­tric can­cer in 2020."