Roche (RHHBY) said the US FDA has accepted the company's Biologics License Application for the fixed-dose combination of Perjeta and Herceptin with hyaluronidase, for the treatment of eligible patients with HER2-positive breast cancer. The FDA decision on the BLA is expected by 18 October 2020.
Levi Garraway, Chief Medical Officer and Head of Global Product Development, said: "Today's acceptance builds upon our commitment by potentially offering patients a faster way to administer Perjeta and Herceptin. We're working with the FDA to bring this treatment option to patients as quickly as possible."
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