' Lin Sun | MTTLR

REMS Helps A Speedy Launch of CAR-T Cell Therapy

I first learned of CAR-T cell therapy in 2015 while working in an immunology lab. It immediately caught my attention as a brilliant, unconventional cancer treatment: it modifies a patient’s own T cells and enlists them to fight cancer. T cells can recognize non-self antigens presented on a cell’s surface, label those cells exogenous, and eliminate them. Scientists have developed CAR-T cell therapy by utilizing these unique characteristics of T cells. Over the past five years, CAR-T cell therapy has made a breakthrough march from bench to bedside. On August 30, 2017, after only seven-month’s review, the Food and Drug Administration (FDA) approved Novartis’ Kymriah, the first CAR-T cell treatment. Kymriah is developed to treat patients up to 25-year-old with relapsed or refractory acute lymphoblastic leukemia (ALL). In October of the same year, the FDA approved the second CAR-T cell therapy, Yescarta. On May 1, 2018, the FDA expanded the use of Kymriah to adult patients with certain types of non-Hodgkin lymphoma. Kymriah and Yescarta are based on the same scientific concept and innovation. Patients’ T cells are engineered by a virus to recognize the CD-19 molecule, a surface bio-marker of both normal and cancerous B cells. These T cells are expanded in vitro and infused back into patients’ blood. Once in the blood of patients, bio-engineered T cells can recognize, attack, and clear B cells which express the CD-19 molecule. Because of its risk and cost, CAR-T cell therapy is generally a last resort. But for cancer patients who have not been successful with conventional treatments, it is a source of great hope. More CAR-T cell therapies are...

SUPPORT-ing Telemedicine

On Oct 3, 2018, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (the SUPPORT Act) passed the legislative process and headed to President Trump’s desk for approval. This sweeping package of bills addressing the opioid crisis gained bipartisan support in Congress. The SUPPORT Act fast-tracked its way through the House and Senate. On June 22, 2018, the House passed a sweeping anti-opioid abuse bill 396-14. And on September 17, the Senate passed its own version of the SUPPORT Act. By October 3, both houses of Congress had passed the final version of the bill. On October 24, President Trump signed the bill. Congress passed the SUPPORT Act in response to the widespread opioid epidemic in the U.S. According to the Centers for Disease Control (CDC), more than 115 people in the U.S. die from an opioid overdose every day. Studies show that about 21 to 29 percent of patients prescribed opioids for chronic pain overdose. Studies also established the correlation between opioid overdose and heroin addiction—about 80 percent of people who use heroin start by misusing prescription opioids. The data on how opioid overdoses have risen over the past two years is striking: The number of overdoses grew 30 percent from July 2016 to September 2017. In the Midwest specifically, the number of opioid overdoses increased 70 percent during that timeframe. The SUPPORT Act permits and encourages telemedicine programs aimed at combating opioid addition by expanding Medicare coverage to cover telehealth services for substance use disorders. Telemedicine and telehealth sound similar but are different concepts. Telemedicine involves “the use of electronic communications and software to provide clinical services to...