Plus   Neg

Roche : EU Okays Polivy For People With Previously Treated Aggressive Lymphoma

Roche (RHHBY) said Tuesday that the European Commission conditionally approved Polivy in combination with bendamustine plus MabThera for the treatment of adult patients with relapsed or refractory or R/R diffuse large B-cell lymphoma who are not candidates for a haematopoietic stem cell transplant.

Conditional approval is granted to a medicinal product that fulfils an unmet medical need where the benefit of immediate availability outweighs the risk of less comprehensive data than normally required.

Diffuse large B-cell lymphoma or DLBCL is the most common form of non-Hodgkin lymphoma, accounting for about one in three cases of NHL. DLBCL is an aggressive type of NHL, which is generally responsive to treatment in the frontline.

The conditional EU approval follows the US Food and Drug Administration's accelerated approval of Polivy in combination with BR for the treatment of people with R/R DLBCL who have received at least two prior therapies, in June 2019.

The company stated that additional submissions of data to health authorities around the world are ongoing with the goal of bringing the new treatment option to more patients as soon as possible.

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