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June 11, 2019

Genentech receives FDA approval for Polivy to treat DLBCL

Genentech has received accelerated approval from the US Food and Drug Administration (FDA) for the use of Polivy (polatuzumab vedotin-piiq) in combination with bendamustine and rituximab (BR) to treat diffuse large B-cell lymphoma (DLBCL) in adults.

Genentech has received accelerated approval from the US Food and Drug Administration (FDA) for the use of Polivy (polatuzumab vedotin-piiq) in combination with bendamustine and rituximab (BR) to treat diffuse large B-cell lymphoma (DLBCL) in adults.

The chemoimmunotherapy regimen is indicated for patients that have relapsed or refractory (R/R) DLBCL and were previously treated with at least two therapies.

Based on Seattle Genetics’ antibody-drug conjugate (ADC) technology, Polivy targets the CD79b protein that is specifically expressed on most of the B-cells.

The drug binds to CD79b and kills these B-cells by delivering an anti-cancer agent. Currently, it is being developed for the treatment of different types of non-Hodgkin’s lymphoma (NHL).

DLBCL is known to be the most common and aggressive form of NHL.

Genentech chief medical officer and global product development head Sandra Horning said: “Despite meaningful progress in the treatment of diffuse large B-cell lymphoma, treatment options are very limited when the disease is refractory to or recurrent after multiple regimens.

“Today’s approval of this Polivy combination will provide a novel treatment that is both immediately available and very much needed for people with this aggressive disease.”

The FDA’s approval comes after a review of findings from the randomised, controlled Phase Ib/II GO29365 clinical trial, where the chemoimmunotherapy regimen demonstrated higher response rates compared to BR in patients ineligible for a hematopoietic stem cell transplant.

According to study data, 40% of patients on Polivy and BR regimen experienced a complete response (CR), when compared to 18% treated with BR alone.

In addition, 45% of subjects in the Polivy combination arm achieved an objective response at the end of therapy versus 18% in the BR group.

Of the patients who had a complete or partial response with Polivy plus BR, 64% showed a duration of response (DOR) lasting at least six months, compared to 30% treated with BR alone.

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