Despite FDA doubts, advisors back first-line Polivy use

Title: Advisors Support First-Line Use of Polivy Despite FDA Doubts


Polivy, a drug developed by Roche, has recently been under scrutiny by the US FDA due to safety concerns. However, a panel of advisors has expressed support for the use of Polivy as a first-line treatment for patients with diffuse large B-cell lymphoma (DLBCL). In this blog post, we will delve into the key points surrounding the controversy, the panel’s decision, and what it means for DLBCL patients.

Key Points:

  1. Understanding Diffuse Large B-cell Lymphoma:

DLBCL is a type of non-Hodgkin’s lymphoma that affects the lymphocytes, a type of white blood cell. It is an aggressive cancer that progresses rapidly, causing symptoms such as enlarged lymph nodes, fever, night sweats, and weight loss. DLBCL is typically treated with chemotherapy, but patients may require additional therapies depending on their disease stage, response to treatment, and other factors.

  1. The Role of Polivy:

Polivy, developed by Roche, is an antibody-drug conjugate that targets CD79b, a protein found in the surface of B-cells, including cancerous B-cells. The drug is intended to enhance the efficacy of chemotherapy in treating DLBCL by delivering a cytotoxic agent directly to cancerous cells. However, concerns regarding its safety profile have arisen concerning liver toxicity and neutropenia seen with its use.

  1. FDA Scrutiny:

The FDA has been scrutinizing the safety profile of Polivy since its initial approval in 2019. The drug was granted conditional approval as a second-line treatment for DLBCL patients, meaning that further studies are needed to confirm its efficacy and safety. However, the FDA expressed concerns regarding the severity of adverse events seen with Polivy, particularly liver toxicity and neutropenia, which may outweigh the benefits.

  1. Panel Decision:

Despite the FDA’s concerns, a panel of advisors has expressed support for the use of Polivy as a first-line treatment option for DLBCL patients. The panel reviewed data from Roche’s phase 1b/2 clinical trial, which showed promising results in patients receiving Polivy as a first-line treatment. In the trial, 80% of patients responded to treatment, and 62% achieved a complete response. While liver toxicity and neutropenia were observed in some patients, the panel was confident that they could be managed with appropriate monitoring and dose adjustments.

  1. Implications for DLBCL Patients:

The panel’s decision to support the use of Polivy as a first-line treatment option brings significant implications for DLBCL patients. It provides a potential new treatment option for patients who may not respond to standard chemotherapy, potentially improving their outcomes. However, patients must also be aware of the potential risks associated with Polivy, such as liver toxicity and neutropenia, and be monitored closely during treatment.

  1. Continuing Research:

While the panel’s decision is a positive development, it is essential to continue monitoring the effectiveness and safety profile of Polivy. The drug’s conditional approval status means that further studies are required to confirm its benefits, risks and fully understand its clinical impact on DLBCL patients.


Polivy has been under scrutiny by the FDA due to safety concerns. Nevertheless, a panel of advisors has expressed support for its use as a first-line treatment option for DLBCL patients. This decision provides hope for patients who need additional treatment options. However, it is essential to monitor the safety and effectiveness of Polivy closely and continue research efforts to provide the best possible outcomes for DLBCL patients. With ongoing efforts, we can continue to make strides in the treatment of cancer and pave the way towards a future with better therapeutic options and diagnosis for cancer patients.