Polivy

Polivy (polatuzumab vedotin) is a prescription medication used in the treatment of certain types of non-Hodgkin lymphoma, particularly diffuse large B-cell lymphoma (DLBCL). Developed by Genentech, a subsidiary of Roche, Polivy is an antibody-drug conjugate that targets CD79b, a protein expressed on the surface of B cells. By binding to CD79b, Polivy delivers a cytotoxic agent directly into the cancer cells, leading to their destruction. Polivy represents a significant advancement in the treatment of diffuse large B-cell lymphoma, offering a targeted approach to therapy. As with all cancer treatments, it is essential for patients to discuss the potential benefits and risks with their healthcare provider to determine the most appropriate treatment plan.

Medical Uses:

1. Previously Untreated DLBCL: In combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP), Polivy is used for the treatment of adults with previously untreated DLBCL, not otherwise specified, or high-grade B-cell lymphoma who have an International Prognostic Index score of two or greater.

2. Relapsed or Refractory DLBCL: In combination with bendamustine and a rituximab product, Polivy is indicated for the treatment of adults with relapsed or refractory DLBCL after at least two prior therapies. 

Mechanism of Action:

Polivy is a CD79b-directed antibody-drug conjugate. Upon binding to the CD79b protein on B cells, the conjugate is internalized, and the cytotoxic agent monomethyl auristatin E (MMAE) is released inside the cell. MMAE disrupts the microtubule network within the cell, leading to cell cycle arrest and apoptosis (programmed cell death). 

Administration:

Polivy is administered as an intravenous infusion. The dosage and treatment schedule depend on the specific regimen and patient factors. It is essential that administration is overseen by a healthcare professional experienced in cancer chemotherapy.

Side Effects:

Common side effects of Polivy include:

• Peripheral neuropathy (tingling and numbness of feet and hands)
• Nausea
• Fatigue
• Diarrhea
• Constipation
• Hair loss
• Mucositis
• Lymphopenia
• Decreased white blood cell count (neutropenia)
• Increased uric acid level in blood
• Anemia (low number of red blood cells)
• Low blood platelets
• Fever
• Decreased appetite
• Pneumonia

Patients should be monitored for these side effects, and supportive care should be provided as necessary.

Approval and Regulatory Status:

Polivy received accelerated approval from the U.S. Food and Drug Administration (FDA) in June 2019 for use in combination with bendamustine and a rituximab product for the treatment of adults with relapsed or refractory DLBCL after at least two prior therapies. In April 2023, the FDA expanded its approval to include combination with R-CHP for previously untreated DLBCL.

In the European Union, Polivy was approved in January 2020 for use in combination with bendamustine and rituximab for the treatment of adult patients with relapsed or refractory DLBCL who are not candidates for hematopoietic stem cell transplant. In March 2022, the European Medicines Agency's Committee for Medicinal Products for Human Use recommended Polivy, in combination with R-CHP or R-CHOP, as a primary treatment for DLBCL.

Safety Precautions:

Before starting treatment with Polivy, patients should inform their healthcare provider about any existing medical conditions, including:

• Liver or kidney problems
• Nerve problems (such as numbness or tingling)
• Recent or active infections

Patients should also inform their healthcare provider about all medications they are taking, including prescription drugs, over-the-counter medications, vitamins, and herbal supplements.

Polivy can cause fetal harm. Women of childbearing potential should use effective contraception during treatment and for at least three months after the last dose. Men with female partners of childbearing potential should use effective contraception during treatment and for at least five months after the last dose.