FDA Approves Roche's Polivy in Combination with Rituximab and Bendamustine for Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Compiled by: Fan Dongdong

This Monday, the U.S. FDA approved Roche’s Polivy (formerly known as polatuzumab) in combination with rituximab and the chemotherapy agent bendamustine for patients with relapsed or refractory diffuse large B-cell lymphoma who have failed at least two prior therapies.

Currently, several of Roche’s lucrative blockbuster cancer drugs are increasingly under attack from biosimilars. However, with the recent FDA approval of Polivy for the treatment of diffuse large B-cell lymphoma (DLBCL), the drug appears to have become the only effective therapeutic option for this patient population. Previously, the FDA had granted Priority Review and Breakthrough Therapy Designation to the Polivy combination regimen.

Polivy ultimately received regulatory approval based on the final results of its Phase 1b/2 pivotal trial. The trial results demonstrated that the Polivy-based combination regimen was superior in efficacy to the standard treatment regimen of bendamustine plus Rituxan. In this trial, 40% of patients treated with the Polivy combination achieved a complete response, compared to only 18% in the bendamustine and Rituxan group. At the end of treatment, 45% of patients in the Polivy combination group achieved an objective response, versus only 18% in the bendamustine and Rituxan group.

Sandra Horning, Chief Marketing Officer at Roche Genentech, stated in a press release that the approval of Polivy “will provide an immediately accessible treatment option for this patient population and also address the unmet need for novel therapies for aggressive disease.” Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma.

It is estimated that there are more than 18,000 new cases of diffuse large B-cell lymphoma (DLBCL) in the United States each year. Although many patients achieve effective disease control after initial treatment, 30%–40% will ultimately experience relapse. Given the progressive nature of the disease, Horning stated, “When patients remain refractory to cure or experience relapse after multiple treatment regimens, therapeutic options become very limited.”

“Antibody-drug conjugates are a novel class of cancer-targeted therapies. Unlike traditional chemotherapy, they can target specific cells,” said Dr. Richard Pazdur of the U.S. FDA’s Center for Drug Evaluation and Research. “The approval of Polivy today provides a new treatment option for patients who have not responded to multiple prior lines of therapy.”

Currently, Roche’s Rituxan, Avastin, and Herceptin are facing increasing competitive threats from biosimilars in the United States and other markets. Last year, these drugs generated combined sales of over $10 billion in the U.S. market; however, Roche anticipates that by the end of this year, all three will suffer significant setbacks in the U.S. market due to biosimilar competition.

Nevertheless, Roche does not appear to have been defeated by generic drugs. To cope with competition, the company launched several new drugs, including Ocrevus for multiple sclerosis, which achieved remarkable sales within its first year on the market, as well as Hemlibra for the treatment of hemophilia.

References:

1、Roche snags first-in-class FDA nod for lymphoma drug Polivy

2、FDA approves first chemoimmunotherapy regimen for patients with relapsed or refractory diffuse large B-cell lymphoma