FDA gives nod to chemoimmunotherapy for patients suffering from DLBCL

Polivy is an innovative antibody-drug conjugate developed with an intention of targeting specific cells

Reports confirm that the US Food and Drug Administration has awarded accelerated approval to Polivy (polatuzumab vedotin-piiq), for use in combination with a rituximab product and chemotherapy bendamustine (BR combination). The drug is expected to treat patients with diffuse large B-cell lymphoma (DLBCL) that has either progressed or returned after two therapies taken previously.

Director of the Oncology Centre of Excellence at FDA and acting director of FDA’s Office of Hematology and Oncology Products, Richard Pazdur commented that as a growing form of targeted immunotherapies made for cancer, antibody-drug conjugates are nothing like traditional therapy.

Antibody-drug conjugates, like Polivy, are developed with the intension of targeting specific cells. Supposedly, there have been several treatments for the disease that have not produced any results, and the approval is expected to help provide these patients with an alternative option, Pazdur informed.

DLBCL affects over 18,000 people annually and about 30-40% of patients often suffer from relapses. This cancer grows quickly and has the potential to affect liver, marrow, spleen and other organs.

Reportedly, a chemotherapy drug is attached with Polivy, an antibody which is created specifically to bind itself to a certain protein called CD79b mainly found in B cells. It then gradually releases the chemotherapy drugs into the cells.

Citing reliable sources, 80 patients with refracted or relapsed DLBCL were studied to evaluate the drug’s success. The patients were randomized while they received Polivy with BR or BR alone. The treatment ended with 40% complete response rate with Polivy and BR, in comparison to 18% with BR alone. 25 patients secured a complete or a partial response to the drug tested out, of which 16 had a Duration of Response of at least 6 months and 12 of them had a Duration Of Response of 12 months.

Polivy had been given the Orphan Drug designation by FDA, a designation which provides incentives to encourage and assist in developments of rare diseases.

Source Credit- https://www.fda.gov/news-events/press-announcements/fda-approves-first-chemoimmunotherapy-regimen-patients-relapsed-or-refractory-diffuse-large-b-cell