The FDA approves Genentech’s lymphoma drug


Genentech, a member of the Roche Group, has announced that the US Food and Drug Administration (FDA) has approved Polivy (polatuzumab vedotin-piiq) in combination with Rituxan (rituximab), cyclophosphamide, doxorubicin, and prednisone (R-CHP).

The approval covers the treatment of adult patients who have not previously been treated for diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL) and who have an International Prognostic Index (IPI) score of two or more.

This FDA decision changed the expedited approval of Polivy in combination with bendamustine and Rituxan for relapsed or refractory (R/R) DLBCL after at least two previous therapies to a regular approval.

DLBCL is an aggressive disease that is difficult to treat and is the most common form of non-Hodgkin lymphoma in the US. Approximately 31,000 people in the US are projected to be diagnosed with DLBCL by 2023. Limited progress has been made in improving patient outcomes in previously untreated DLBCL over the last two decades. While many patients are responsive to initial treatment, as many as four in 10 people with DLBCL do not respond or relapse. For people on standard-of-care initial treatment, Rituxan plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP), most relapses occurred within two years of starting treatment, and the majority of those who required further therapy did worse. results.

“It has been almost 20 years since a new treatment option became available to people newly diagnosed with disseminated large B-cell lymphoma,” said Levi Garraway, chief medical officer and head of Global Product Development.

“Today’s decision from the FDA to approve Polivy in combination with R-CHP in this setting brings about a much needed new treatment option that may improve outcomes and bring other benefits to many patients with this aggressive lymphoma.”

Genentech sees ‘significant improvement’

FDA approval of Polivy plus R-CHP for first-line treatment of DLBCL is based on important data from POLARIX, an international, randomized, double-blind, placebo-controlled study showing statistically significant and clinically significant improvement in PFS compared to R-CHOP .

The risk of disease progression, relapse or death was reduced by 27% with Polivy plus R-CHP compared with R-CHOP.

The approval follows an 11-to-2 FDA Oncology Drug Advisory Committee (ODAC) vote in favor of Polivy in combination with R-CHP for previously untreated DLBCL. More than 70 countries have approved the Polivy combination for the treatment of adult patients with previously untreated DLBCL, including in the EU, UK, Japan, Canada and China. Polivy in combination with R-CHP was recently added to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) as category 1, the regimen of choice for first-line DLBCL.

Polivy in combination with bendamustine and Rituxan is currently approved in more than 80 countries worldwide for the treatment of adults with relapsed or refractory (R/R) DLBCL after one or more previous therapies, including in the US.

Genentech said it is continuing to explore areas of unmet need where Polivy has the potential to provide additional benefit, including in ongoing studies investigating the combination of Polivy with the company’s CD20xCD3 T cells involving the Lunsumio bispecific antibody (mosunetuzumab-axgb) or glofitamab.

The trials included the phase III SUNMO study in combination with Lunsumio in patients with R/R DLBCL and the phase III POLARGO study with Rituxan in combination with gemcitabine and oxaliplatin in patients with R/R DLBCL.

About diffuse large B-cell lymphoma

Diffuse large B-cell lymphoma (DLBCL) is the most common form of non-Hodgkin lymphoma (NHL), accounting for about one in three cases of NHL. DLBCL is an aggressive (fast growing) type of NHL. Although generally responsive to frontline treatment, as many as 40% of people will relapse or have refractory disease, in which rescue therapy options are limited and survival is short. It is estimated that around 160,000 people worldwide are diagnosed with DLBCL each year.

About Polivy Genentech (polatuzumab vedotin-piiq)

Polivy Genentech is a class one anti-CD79b drug-antibody (ADC) conjugate. The CD79b protein is expressed specifically in most B cells, an immune cell that impacts several types of NHL, making it a promising target for the development of new therapies. Polivy binds to cancer cells such as CD79b and destroys these B cells through delivery of anti-cancer agents, which is thought to minimize effects on normal cells.

Polivy is being developed by Genentech using Seaagen’s ADC technology and is currently being investigated for the treatment of certain types of NHL.

Genentech’s Additional Biological License application for Polivy was approved by the FDA last August.


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