(CercleFinance.com) – Roche announces that the FDA has accepted the Supplemental Biologics License Application (sBLA) for a combination including Polivy and Rituxan for the treatment of previously untreated diffuse large B-cell lymphoma (DLBCL).
The application is based on pivotal data from the Phase III POLARIX study showing a dramatic reduction in the risk of disease progression, relapse or death with safety comparable to standard of care.
The United States health authority is expected to make a decision on approval by April 2, 2023. Various combination studies with Polivy and the company’s CD20xCD3 bispecifics in diffuse large B-cell lymphoma are ongoing.
Although this aggressive blood cancer often responds to initial treatment, it is not cured with the current standard of care in four out of 10 people. Most relapses occur within two years of starting treatment.
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