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First Chemoimmunotherapy Regimen Granted Accelerated Approval for Patients with Previously Treated DLBCL

Web Exclusives - FDA Approvals, In the News
Yvette Florio Lane

On June 10, 2019, the US Food and Drug Administration (FDA) granted accelerated approval to the novel antibody-drug conjugate polatuzumab vedotin-piiq (Polivy; Genentech) in combination with bendamustine plus rituximab for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) that has progressed or returned after at least 2 previous therapies. This is the first chemoimmunotherapy regimen approved for use in patients with DLBCL who are ineligible for hematopoietic stem-cell transplantation.1,2

Polatuzumab vedotin-piiq attaches to a chemotherapy drug and binds to the CD79b protein, which is found exclusively in B-cells. Once bound to CD79b, polatuzumab vedotin-piiq releases the chemotherapy drug into the B-cells.

“Antibody-drug conjugates are an emerging class of targeted immunotherapies for cancer. This type of therapy, unlike traditional chemotherapy, is intended to target specific cells,” said Richard Pazdur, MD, Director, Oncology Center of Excellence, and Acting Director, Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, FDA, Silver Spring, MD.

The accelerated approval was based on results from the phase 1B/2 GO29365 clinical trial, which included 80 patients who were randomized to receive polatuzumab vedotin-piiq with bendamustine plus rituximab or bendamustine plus rituximab alone.2 The complete response rate was 40% in patients who were treated with polatuzumab vedotin-piiq plus bendamustine plus rituximab compared with 18% in those treated with bendamustine plus rituximab alone.2 Of the 25 patients who achieved a partial or complete response to polatuzumab vedotin-piiq plus bendamustine plus rituximab, 16 (64%) had a duration of response of at least 6 months and 12 (48%) had a duration of response of at least 12 months.2

“Today’s approval of Polivy provides an alternative option for patients in whom multiple treatments have not worked,” said Dr Pazdur.

The most common adverse reactions associated with polatuzumab vedotin-piiq plus bendamustine plus rituximab include neutropenia, thrombocytopenia, and anemia; peripheral neuropathy; fatigue; diarrhea; fever; decreased appetite; and pneumonia. Infusion-related reactions, low blood counts, and fatal and/or serious infections are possible with this treatment and should be monitored. Other serious and potentially fatal adverse events, including tumor lysis syndrome, hepatotoxicity, and progressive multifocal leukoencephalopathy, may also occur.1

Female patients in their reproductive years should use effective contraception and should avoid pregnancy for 3 months after taking their last dose of polatuzumab vedotin-piiq. Women who are pregnant or breastfeeding should not take polazutumab vedotin-piiq because it may cause harm to a developing fetus or newborn baby.1

More than 18,000 people in the United States are diagnosed with DLBCL each year. Although it is curable, the relapse rate associated with DLBCL is approximately 30% to 40%.1

The FDA grants conditional approval to a drug or device that fills an unmet medical need for a serious condition through its Accelerated Approval Program. Continued approval for this indication requires verification of clinical benefit through a confirmatory trial. The FDA’s Priority Review designation is granted to drugs thought to have the potential to provide significant improvements in the safety and effectiveness of the treatment, prevention, or diagnosis of a serious disease. The FDA also gave polatuzumab vedotin-piiq orphan drug status.


References

  1. US Food and Drug Administration. FDA approves first chemoimmunotherapy regimen for patients with relapsed or refractory diffuse large B-cell lymphoma. June 10, 2019. www.fda.gov/news-events/press-announcements/fda-approves-first-chemoimmunotherapy-regimen-patients-relapsed-or-refractory-diffuse-large-b-cell. Accessed June 10, 2019.
  2. Business Wire. FDA grants Genentech’s Polivy accelerated approval for people with previously treated aggressive lymphoma. June 10, 2019. www.businesswire.com/news/home/20190610005588/en. Accessed June 10, 2019.
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Last modified: June 12, 2019