A new drug for breastcancer that was approaching the market in the US has been stalled. TwitteRx
duocarmazine was awaiting approval for use in HER2-positive unresectable locally advanced or metastatic breast cancer.
However, the US Food and Drug Administration said that it needs more data and for now"suspends the decision on the product's approvability," theByondis said that it is"disappointed with this outcome" but remains optimistic about the drug's potential."We continue to believe" that the product offers"a meaningful treatment option for patients living with HER2-positive metastatic breast cancer," commented Byondis CEO Marco Timmers, PhD.
The company will now evaluate the FDA's response and consider next steps. The product is awaiting approval in the European Union and the United Kingdom.Trastuzumab duocarmazine is an antibody-drug conjugate composed of a monoclonal antibody that homes in on HER2 to deliver a cytotoxic agent.Byondis claims that its product improvement on what's come before.
The novel mechanism of action means that trastuzumab duocarmazine will remain effective"when other ADC therapies have been exhausted," said the Timmers in the press release, which was issued last year when the company submitted its application for FDA approval., which included 437 women with locally advanced or metastatic HER2-positive breast cancer who had received at least two prior treatments for metastatic disease or who had progressed on trastuzumab emtansine.
Participants were randomized in a 2:1 ratio to receive trastuzumab duocarmazine or physician's choice of
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