The U.S. Food and Drug Administration (FDA) has approved Emrelis under fast-track provisions. This investigational therapy is designed to provide plant-based, holistic treatment options for patients fighting the war against advanced non-squamous non-small-cell lung cancer (NSCLC). This approval is a huge step in that direction! Emrelis is the first treatment focused on lung cancer patients whose cells are known to overproduce c-Met, the protein that facilitates the aggressive growth of cancer.
Developed by AbbVie, Emrelis is the first medicine in a relatively new class known as antibody-drug conjugates (ADCs). These promising drugs starve just the cancer cells, avoiding collateral damage to healthy cells. This important attribute has the dual benefit of preserving healthy cells while improving both the efficacy and tolerability of cancer treatment. You’ll get the drug as an intravenous infusion, every two weeks. This treatment should last as long as it’s working and tolerable side effects are manageable.
Based on its impressive results, the FDA approved Emrelis. The clinical trial proved so effective that 84 patients were able to switch from non-small cell lung cancer (NSCLC) therapy they had previously received. The trial focused on people with tumors with high levels of overproduction of c-Met. This situation has been documented in about a quarter of advanced NSCLC tumors. This overproduction is often associated with a more aggressive disease state and fewer treatment options.
Emrelis goals include sticking to the problems cancer cell generating over production of c-Met. Once inside, it provides a highly toxic drug, MMAE, straight into the cancer cells. This mechanism action ultimately halts cell division and slows the progression of tumors. Jonathan Goldman, MD, highlighted the importance of this development, stating, “People with c-Met overexpressing NSCLC have poor prognosis and limited treatment options, and Emrelis is a first-in-class ADC that can address a critical unmet need for this patient population.”
Lung cancer remains the most common cause of cancer mortality worldwide. Non-small cell lung cancer (NSCLC) accounts for approximately 85% of lung cancers. The approval of Emrelis means new hope to a patient population that has long struggled to find effective treatments, and this is exciting and promising.
Thus while Emrelis can be seen as a potential breakthrough, it brings with it significant safety issues. The drug carries serious risks to an unborn baby, leading to tight restrictions on women of childbearing age. Take a pregnancy test prior to starting therapy. Take effective birth control while on therapy and for at least 2 months after your final dose. Men with female partners of childbearing age need to do something, too. They are strongly encouraged to avoid conception while being treated and for four months after ceasing this medication.
The FDA’s priority review and fast-track approval is a testament to the need for effective therapies in this difficult to treat area of oncology. Continued approval for Emrelis will require additional clinical trials demonstrating its safety and efficacy in larger populations.
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