MacroGenics Gets Nod For Margenza In HER2-Positive Breast Cancer
Company Reaches Milestone With First FDA Approval
The drug may see a muted launch given the competitive landscape and a broad label despite its efficacy advantage in F-allele patients.
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Public Company Edition: The last biopharma IPO in the US was on 17 February and none have been scheduled, so far, for March. Also, another SPAC merger is called off, Travere sells $275m worth of notes and Xeris secures $150m in new debt, while Ovid, Passage Bio and others are cutting jobs.
While the general lack of an overall survival benefit for MacroGenics’ drug in later-line breast cancer was not surprising, OS data were seen as important for commercial uptake of the drug.
Top-line results from the Phase III TULIP study show that Byondis’s next-generation antibody-drug conjugate, trastuzumab duocarmazine (SYD985) is superior to physicians' choice of therapy for delaying disease progression in patients with advanced HER2-positive breast cancer.