FDA is­sues CRL to small Dutch biotech's breast can­cer ADC as OS fig­ures fail to im­press

The FDA has bat­ted back an ap­pli­ca­tion for a po­ten­tial breast can­cer ther­a­py.

US reg­u­la­tors is­sued a com­plete re­sponse let­ter to the small Dutch biotech Byondis, re­ject­ing its pitch for an an­ti­body-drug con­ju­gate com­bin­ing Her­ceptin with the com­pa­ny’s ex­per­i­men­tal drug duo­car­mazine. Byondis did not say what prompt­ed the CRL, not­ing on­ly in a press re­lease that the FDA want­ed more in­for­ma­tion re­quir­ing “time and re­sources that ex­tend be­yond the cur­rent eval­u­a­tion pe­ri­od.”

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