FDA Approves a Combination of Drugs for Diffuse Large B-cell Lymphoma

 

Diffuse large B-cell lymphoma  (DLBCL) is a common type of non-Hodgkins lymphoma. World Pharma News recently reported that the FDA approved the first chemoimmunotherapy, Polivy, for DLBCL in combination with two drugs known collectively as “BR” .

About Diffuse Large B-cell Lymphoma (DLBCL).

Each year, over eighteen thousand people in the United States, mostly adults, receive a diagnosis of DLBCL. After being treated, about forty percent of patients relapse.

DLBCL is a cancer that originates within the lymphatic system, a network that fights disease.

The disease grows uncontrollably in the lymph nodes and can affect the spleen, bone marrow, liver, and other organs.

The symptoms may involve fever, swollen lymph nodes, weight loss, and night sweats.

Of the 61 types and subtypes of non-hodgkin lymphoma, DLBCL is the most common form.

About the Approved Drug Combination

FDA granted accelerated approval to Polivy (polatuzumab vedotin-piiq).

POLIVY is combined with BR, which is a combination of bendamustine together with a product called rituximab. The combination was approved to treat DLBCL patients.

Polivy is a novel antibody drug conjugate (ADC). ADCs are a new class of cancer immunotherapies that unlike standard chemotherapy, targets very specific cells and spares healthy cells.

Polivy attaches to BR which binds to CD79b, a protein found on B cells (white blood cells). It releases the chemotherapy into the B cells.

BENDAMUSTINE is an anti-cancer chemotherapy drug. It is listed in one of five traditional categories of alkylating agents and is administered as an injection through the vein.

RITUXIMAB, a chimeric monoclonal antibody, targets the CD20 protein which is usually found on the surface of immune system B cells. The antibody binds to CD20 resulting in the death of the cell.

Chimeric antibodies can conform to any application. Therefore, researchers are able to choose a monoclonal antibody then adapt it to a binding surface.

About Polivy plus BR’s Common Side Effects

Low blood counts may occur such as:

  • Neutropenia (low white blood cells)
  • Platelets (thrombocytopenia)
  • Red blood cells (anemia), or possibly
  • Nerve damage (peripheral neuropathy)

Other common side effects may be fever, fatigue, diarrhea, decreased appetite or pneumonia.

Evaluation

Eighty patients whose disease had progressed or returned after two or more prior therapies were randomized to receive either Polivy with BR or receive BR as a single agent.

The goal of the study was to compare the efficacy of the combination versus BR alone.

At the conclusion of the study, the results showed a complete response rate of 40% for Polivy plus BR as compared to only 18% for BR alone.

Sixteen patients who showed either a partial or complete response to Polivy plus BR had a durable response rate of six months. While twelve patients had a durable response rate of about twelve months.

Some of the patients involved with the study experienced the usual adverse events. However, infusion-related reactions such as severe and even fatal infections were reported.

All professionals who may be responsible for administering the drugs are advised to closely monitor patients in the event of complications such as tumor lysis syndrome, damage to the liver, and infections such as possible brain infection.

FDA also cautions women to use contraceptives when they are receiving Polivy therapy. In addition, the Agency gives special instructions and warnings when women are in treatment while breastfeeding

ABOUT FDA APPROVALS

The accelerated approval granted to Polivy and BR is based on the success of drugs that fill a medical need where no other effective treatment is available to patients. Additional trials will be necessary to verify the drugs’ effect on DLBCL.

The application by Polivy’s developer, Genetech, was also granted Breakthrough Therapy and Priority Review designations.

These designations are designed to expedite the development of drugs that demonstrate a significant advantage over available therapy.

Orphan Drug designation, providing incentives to create drugs to conquer rare diseases, was granted to Polivy as well.

What is your opinion about the benefits versus the risks of some of the newly approved drugs?

 


Rose Duesterwald

Rose Duesterwald

Rose became acquainted with Patient Worthy after her husband was diagnosed with Acute Myeloid Leukemia four years ago. He was treated with a methylating agent While he was being treated with a hypomethylating agent, Rose researched investigational drugs being developed to treat relapsed/refractory AML.

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