Genentech Develops FDA Approved Regimen to Treat DLBCL

Genentech Develops FDA Approved Regimen to Treat DLBCL

By Pharma Tech Outlook | Thursday, June 27, 2019

The lack of treatment for DLBCL patients facing recurrence has necessitated innovation in the treatment regimens for the aggressive disease.

FREMONT, CA: The aggressive diffuse large B-cell lymphoma (DLBCL) tumor can arise in any part of the body, leading to the development of cancerous glands. Around 3 out of 4 people survive the tumor, and less than half are completely cured after the treatment. Over the years, many steps have been taken in the direction of improving the treatment.

Recently, the efforts of Genentech spurred the U.S. Food and Drug Administration (FDA) to approve the use of polatuzumab vedotin-piiq (Policy) with bendamustine and rituximab (BR) in the treatment of DLBCL in adults. The chemoimmunotherapy treatment is designed for relapsed patients previously treated with at least two other therapies.

DLBCL is the most common and dangerous form of non-Hodgkin’s lymphoma (NHL). Policy leverages the Seattle Genetics’ antibody-drug conjugate (ADC) technology to target the CD79b protein mostly found in the B-cells. It clings to the CD79b and terminates the B-cells using anti-cancer agents. The drug is currently in development for the treatment of NHL.

Although the medical sector has witnessed progress in the treatment of DLBCL, the regimen options are quite limited for patients facing a recurrence of the disease. In this regard, the approval of the Polivy combination will significantly enhance the treatment of hostile disease.

The FDA reviewed the results from a controlled phase Ib/II GO29365 clinical trial conducted on a random sample before passing the approval. The study revealed that the chemoimmunotherapy regimen is more effective when compared to BR in patients ineligible for hematopoietic stem cell transplant.

According to the results, 40 percent of the patients on Polivy and BR regimen experienced complete response (CR) whereas only 18 percent of the patients on BR achieved CR. Around 45 percent of the patients on Polivy and BR experienced an objective response, and only 18 percent on BR achieved it. Also, of all the patients who showed complete or partial response with the Polivy and BR combination, around 64 percent experienced a duration of response (DOR) which lasted for half a year when compared to 30 percent who were treated with BR.

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