RE:Byondis' breast cancer drug fails to bloom as FDA denies appByondis B.V. (formerly Synthon Biopharmaceuticals) failed to provide PPS, ORR or evolving OS from a Phase 2 clinical trial prior to applying for a Phase 3 clinical trial, thus precluding the company from filing an accelerated approval before the company's completed their Phase 3 and filed the BLA.
With this BLA, Byondis sought approval for its anti-HER2 antibody-drug conjugate (ADC) in HER2-positive unresectable locally advanced or metastatic breast cancer (MBC), a disease with a high unmet medical need.
It seems evident that the design of Byondis' Phase 3 clinical trial was the cause of this week's FDA complete response letter (CRL) requesting additional information [likely safety, effectiveness and more mature OS data given ADCs high toxicities and low efficacy profile] that requires time and resources that extend beyond the current evaluation period submitted to the FDA.
https://www.adcreview.com/nct03262935-tulip-clinical-trial-syd985/