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Drug Developments: FDA’s Approval & More

Emma Yasinski
Emma Yasinski Staff Writer

The leukemia drug Mylotarg (gemtuzumab ozogamicin), which was voluntarily withdrawn from the market in 2010 over safety concerns and questions about its efficacy, is available again. The FDA has approved the biologic for adults with newly diagnosed acute myeloid leukemia and for patients at least 2 years old who have had a relapse or didn’t respond to prior treatment. Mylotarg originally received accelerated approval in 2000 for older adults who had experienced a relapse. But it was removed from the market after patient deaths and a lack of clinical benefit were observed in confirmatory trials. With the new approval, Mylotarg now has a lower recommended dose, a different schedule of how often the drug is given, and a different patient population. Pfizer, Mylotarg’s manufacturer, presented the FDA with additional data, analysis and research from clinical trials that lasted for 10 years in support of re-approval. The FDA said it allowed Mylotarg’s return after careful examination and based on the benefits outweighing the risks. Posted September 1, 2017. Via FDA.

Novo Nordisk has agreed to pay $58 million over allegations that some of its sales representatives downplayed a cancer risk associated with its diabetes drug Victoza (liraglutide) in marketing to doctors. When Victoza was approved in 2010, the FDA mandated it come with a Risk Evaluation and Mitigation Strategy (REMS) that required the drugmaker to provide information regarding Victoza’s potential risk of medullary thyroid carcinoma (MTC) — a rare form of cancer associated with the drug — to physicians. According to a complaint filed by the US Department of Justice (DOJ), some Novo Nordisk sales representatives created a misleading impression that the cancer risk associated with Victoza was incorrect or unimportant. In addition, they failed to accurately report important data regarding the drug’s safety and efficacy. The DOJ also noted that a survey in 2011 found that half of primary care doctors polled said they did not know about the MTC risk. Posted September 5, 2017. Via US Department of Justice.

The FDA has approved the first-ever gene therapy, Kymriah (tisagenlecleucel), as a treatment for children and young adults for a type of leukemia. The immunotherapy is considered a breakthrough since it is made using the patient’s own T-cells, white blood cells that are part of the body’s immune system that fight infections and cancer. Kymriah is custom-made for each patient. A patient’s T-cells are sent to a manufacturing facility and then modified genetically to include a gene that has a specific protein that tells the T-cells to find and kill leukemia cells. After the modification, the T-cells are infused back into the patient. Researchers found that Kymriah led to remission of acute lymphoblastic leukemia in 83% of 63 children and young adult patients within 3 months. Despite the benefits, the treatment carries risks, including a boxed warning about a potentially fatal immune reaction known as cytokine-release syndrome. Other severe side effects seen with Kymriah include serious infections, low blood pressure (hypotension), acute kidney injury, fever and decreased oxygen (hypoxia). Because of these risks, the FDA is requiring that hospitals and clinics that want to dispense Kymriah need to be certified and their staff involved in the treatment trained to recognize and manage symptoms. Posted August 30, 2017. Via FDA.

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