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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April 17, 2026 15:29 ET The ongoing conflict in the Middle East continues to raise concerns for policymakers who worry about the impact of the supply shock and high energy prices on the real economy. Producer price data and various survey results on the housing market were the main news from the U.S. this week. In Europe, industrial production data for the euro area gained attention. GDP figures out of China and the policy move by the Singapore central bank were in focus in Asia.