FDA Approves Zenocutuzumab for Advanced Lung and Pancreatic Cancers

Zenocutuzumab approved by FDA for advanced lung and pancreatic cancers with NRG1 fusion, providing a new treatment option for patients.

Highlights:

Zenocutuzumab blocks HER2/3 proteins to treat NRG1 fusion cancers
FDA's approval is based on promising clinical trial results
Ongoing trials will confirm long-term clinical benefits

A new cancer treatment is approved under the brand name Bizengri by the U.S. Food and Drug Administration (FDA), which it granted accelerated approval. Zenocutuzumab targets adults whose advanced NSCLC (non-small-cell lung carcinoma) or pancreatic cancers have a NRG1 (Neuregulins 1) fusion. The treatment is the first to address cancers with NRG1 fusion that have progressed or could not be operated on surgically and, despite receiving previous treatments, have deteriorated ().

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‘Did You Know?
#Zenocutuzumab targets specific fusion proteins to slow down cancer growth. #medindia #targetedtherapy’

What is NRG1 Fusion?

A very rare gene alteration is identified through NRG1 fusion and occurs more in cancers involving the pancreatic and lung parts. When these abnormal proteins are secreted, signals are formed to encourage growth and movement of the cancerous tumour. Thus, cancer types tend to grow more virulent and fail to regress under standard therapeutic applications.

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Mechanism of Action of Zenocutuzumab

Zenocutuzumab is an antibody-drug conjugate that involves the body's immune response mechanism to combat cancer. Zenocutuzumab acts by inhibiting the two proteins, namely, HER2 and HER3 in the cancer cells. They otherwise bind with NRG1 fusion proteins, which otherwise triggers the growth of tumour. Inhibiting such interaction can slow the pace of growth and spread of cancers by zenocutuzumab. It could further enhance the process where the immune system kills those cancer cells.

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Bizengri Demonstrates Activity in Advanced Lung and Pancreatic Cancers

Bizengri is administered every other week as an infusion. This product is expected to enter the market shortly. This is according to a release from Merus N.V., the company which designed the drug.

Clinical studies were conducted in 64 adults with advanced NSCLC and 30 adults with advanced pancreatic cancer harboring NRG1 fusions. Patients were previously treated with other drugs that were not successful.

For the patients suffering from NSCLC, the tumor size was reduced by 33%, which was maintained for a mean period of 7.4 months.
For the patients with pancreatic cancer, the size of the tumors was reduced by 40%, which lasted from 3.7 to 16.6 months.
The results are promising but approval of Bizengri continues to depend on confirmation in additional clinical trials.

Side Effects of Bizengri:

Like many cancer treatments, Bizengri may cause side effects. Some of the most common side effects include:

Muscle pain
Fatigue
Rashes
Infusion reactions
Breathing difficulties
Nausea, diarrhea, constipation, vomiting, stomach pain
Swelling

Major side effects will include altered liver enzymes, blood dyscrasias, and hyponatremia. Patients are also advised that Bizengri is toxic to the unborn fetus and therefore women should ensure they are not pregnant and if they are sexually active should use contraception during treatment and one month and two subsequent months after the treatment. Patients having heart or lung diseases should consult their doctor before using this medicine.

Thus, Zenocutuzumab is a promising bet for the treatment of advanced non-small-cell lung cancer and pancreatic cancer with NRG1 fusion. Because it aims at deactivating proteins which are a unique recourse to tumor growth, the treatment presents new hope to patients with no other options. But, its further approval and efficiency are subject to new clinical trials only.

Reference:

FDA grants accelerated approval to zenocutuzumab-zbco for non-small cell lung cancer and pancreatic adenocarcinoma - (https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zenocutuzumab-zbco-non-small-cell-lung-cancer-and-pancreatic)

Source-Medindia

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