Roche has cleared a barrier to the use of Gazyvaro over biosimilar copies of its collapsing blockbuster MabThera. Gazyvaro, known as Gazyva in the U.S., is now cleared for use over the same accelerated 90-minute infusion time as MabThera in follicular lymphoma patients in the EU.
Years ago, Roche showed healthcare professionals can give MabThera, also known as Rituxan, over a 90-minute infusion. If a patient is free from grade 3 or 4 infusion-related reactions in cycle 1, later infusions of MabThera can be given over 90 minutes, rather than the three to four hours it typically takes. The shorter time reduced the burden ongoing treatment places on infusion sites and patients.
Now, with biosimilars eating away at MabThera sales, Roche has secured EU approval for the 90-minute administration of its successor, Gazyvaro. Again, Roche has cut the infusion time from three to four hours to 90 minutes.
“Reducing the amount of time patients need to be in hospital has the potential to improve their treatment experience whilst also increasing efficiency for institutions and healthcare systems,” Levi Garraway, M.D., Ph.D., chief medical officer at Roche, said in a statement. Roche sees particular benefits to giving Gazyvaro over a shorter time amid the healthcare problems caused by the pandemic.
European authorities signed off on the truncated infusion timeline after seeing data from a clinical trial that gave Gazyvaro over 90 minutes. No patient had a grade 3 or worse infusion-related reaction after receiving a 90-minute infusion in the second cycle of treatment. One patient had grade 3 hypertension in the fifth cycle, but all other infusion-related reactions were grade 1 or 2.
Roche is immediately implementing a label update and aiming to launch short-duration Gazyvaro in the EU “as soon as possible.”