Navelbine (Vinorelbine)

Navelbine is the brand name of the chemotherapy drug called vinorelbine. It is a semi-synthetic compound that is thought to slow tumor growth by preventing cancer cells from growing and processing certain internal structures. Navelbine is currently approved by the U.S. Food and Drug Administration (FDA) for treating certain cases of non-small cell lung cancer. It is approved in Europe for mesothelioma and other types of cancer.

It is not approved for treating any type of mesothelioma, and yet Navelbine is showing promise as a treatment for this difficult cancer. It may be a good second-line chemotherapy drug, extending patients’ lives and helping them live more comfortably and enjoy a better quality of life. More studies are needed and doctors and patients must weigh the benefits of this drug against the side effects and potentially serious health risks.

What is Navelbine?

Navelbine is a brand name drug—generic name vinorelbine—that is made by Pierre Fabre Pharmaceuticals in France and distributed in the U.S. It was first approved by the FDA in 1994 and is now available as a generic and is made by other drug manufacturers. It is approved by the FDA to treat non-small cell lung cancer as a chemotherapeutic agent. It is administered like most chemotherapy drugs, through intravenous injection, but an oral formulation has been developed and is used in Europe. It is not approved in the U.S.

Approved uses for non-small cell lung cancer, which may sometimes be caused by workplace asbestos exposure, is as a first-line treatment in combination with cisplatin in patients with advanced or metastatic cancer and as a single agent treatment. Although not approved for other uses, Navelbine is sometimes used to treat breast cancer and some soft tissue sarcomas. It is increasingly being tested for use in mesothelioma patients. In some other countries, particularly in Europe, Navelbine has been approved as a chemotherapy treatment for mesothelioma.

How it Works

Vinorelbine belongs to a class of drugs called the vinca alkaloids. These are drugs that act on microtubules in cells to disrupt the division into new cells. Microtubules are proteins in all cells that must align in a certain way in order for cells to divide successfully and produce new cells. This process gets disrupted by alkaloids like vinorelbine, which causes cancer cells to stop dividing and slows the growth of tumors. It also targets other fast-growing cells in the body, including healthy cells. Vinorelbine is semi-synthetic; it originated in a plant called Madagascan periwinkle, but is made synthetically in the laboratory.

Side Effects of Navelbine

As with many types of chemotherapy drugs, Navelbine does not just target cancer cells in the body. When given intravenously it targets all fast-growing cells, those in the process of dividing. This means it harms healthy cells and causes some characteristic side effects as a result. The most commonly reported side effects with vinorelbine are nausea, vomiting, weakness, a reaction at the injection site, constipation, peripheral neuropathy, elevated liver enzymes, anemia, and low white blood cell count. It may also cause mouth sores, dizziness, diarrhea, loss of appetite and weight loss, muscle, bone, and joint pain, hair loss, and headaches.

Navelbine also carries a black box warning, the FDA’s most severe warning regarding the most serious and potentially life-threatening side effects possible with a drug. For Navelbine this warning is about bone marrow suppression. Because it targets fast-growing cells, the cells in bone marrow that produce new blood cells can be damaged by the drug. These include cells that produce the white blood cells of the immune system. The risk is that vinorelbine can cause severe suppression of bone marrow, which in turn can lead to serious and possibly fatal infections. Patients must be screened carefully for compromised immune systems and white blood cell counts before and during treatment with this drug.

Navelbine and Mesothelioma

Vinorelbine is not approved for treating mesothelioma and it is not often used, but it is under study as a treatment for this cancer. In one phase II clinical trial 29 patients with pleural mesothelioma were given weekly injections of the drug. The patients included various stages of the disease—from early to advanced—and the purpose of the trial was to evaluate how the tumors responded, but also to determine if it had an impact on the each patient’s quality of life. Sometimes chemotherapy drugs are given to improve cancer symptoms to make patients more comfortable, especially with cancers that are tough to defeat with any treatment.

The results were promising in this small clinical trial. About one-quarter of the patients had a partial response, which means their tumors shrank to some degree. Fifty percent of the participants experienced a stable response; their tumors did not shrink or grow during the study period. Twenty-one percent of patients’ disease progressed; their tumors grew. The overall result on quality of life was positive. The researchers concluded that there should be ongoing studies with vinorelbine because of the positive response, as a palliative treatment, and because the side effects were minimal for the participants.

Another clinical trial with Navelbine involved 63 patients with mesothelioma who also received six weeks of weekly injections of the drug. These patients had already received chemotherapy, so it was being used as a second-line treatment. Sixteen percent of patients responded to it and the average survival time was nearly ten months. The toxicity was not a big issue for most patients, with bone marrow suppression being the most significant problem. The researchers here also concluded that vinorelbine holds promise as a treatment for mesothelioma and should be studied further.

Navelbine is a promising chemotherapy drug for patients with mesothelioma. The number of studies and the patients who have had access to it in the U.S. are limited, but the results show that more study is needed and that this drug could extend lives and improve quality of life for many patients with mesothelioma. Already approved for use in Europe, it may just be a matter of time before Navelbine is available in the U.S. In the meantime, patients with mesothelioma can talk to their doctors about the possibility of being enrolled in a clinical trial with the drug or with others that are still being tested.