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FDA Expands Use of Melanoma Drug, May Benefit Mesothelioma Patients

When the FDA provides approval for medications in the treatment of specific conditions, it is not at all uncommon for physicians to try to find uses outside of that specific purpose, to see whether the drug is equally beneficial for other conditions. This practice is known as off-labeling, and it is neither illegal nor uncommon. Though physicians are free to prescribe a medication once it has been approved, the practice may be frowned upon, especially because the drug in question has likely not been tested on patients suffering from the other conditions, and side effects are an unknown. Still, when treating those suffering from fatal diseases such as mesothelioma, doctors are often willing to take the risk and try alternative treatments, while hoping that the FDA will eventually grant approval.

That is exactly what has happened with a drug called Opdivo. Created by Bristol-Myers Squibb, Opdivo is a programmed death receptor-1 therapy that was original created for the treatment of melanoma. Lab studies have also shown that it is effective in extending the survival of patients who have previously been treated for metastatic squamous non-small cell lung cancer, and now the FDA has expanded its approval use to lung cancer therapy. The move, which was anticipated, came earlier than expected and is good news for mesothelioma patients who have previously been treated with platinum-based chemotherapy.

Mesothelioma is frequently found to be chemotherapy resistant, and as a result patients who are treated with Pemetrexed or other platinum-based drugs often relapse after the protocol is complete. The availability of Opdivo expands these patients’ options.

In a statement released by Bristol-Myers Squibb, company CEO Lamberto Andreoti said, “Bristol-Myers Squibb is committed to patients with lung cancer, and w are pleased to offer Opdivo as the first immune-oncology therapy for patients who have previously treated metastatic squamous NSCLC.” Echoing his enthusiasm, Dr. Suresh Ramalingam, MD, Professor and Director of Medical Oncology at the Winship Cancer Institute of Emory University, says, “The FDA approval of Opdivo introduces an entirely new treatment modality that has demonstrated unprecedented results. This milestone brings to fruition the long-held hope that immuno-ocology medicines can be significantly effective in this difficult-to-treat population.”

Terri Oppenheimer

Terri Oppenheimer is an independent writer, editor and proofreader. She graduated from the College of William and Mary with a degree in English. Her dreams of a writing career were diverted by a need to pay her bills. She spent a few years providing copy for a major retailer, then landed a lucrative career in advertising sales. With college bills for all three of her kids paid, she left corporate America for a return to her original goal of writing. She specializes in providing content for websites and finds tremendous enjoyment in the things she learns while doing her research. Her specific areas of interest include health and fitness, medical research, and the law.

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