FDA approves cancer breakthrough that costs $375000 per treatment

Dash cam video shows a deputy-involved shooting at a Dollar General in Carroll County

Dash cam video shows a deputy-involved shooting at a Dollar General in Carroll County

In this study, 72% of patients treated with a single infusion of Yescarta (n = 101) responded to therapy (overall response rate), including 51% of patients who had no detectable cancer remaining (complete remission; 95% confidence interval [CI], 41-62). Due to potential toxicities, the approval is subject to a risk evaluation and mitigation strategy to ensure patient safety.

The Yescarta treatment manufactured by the Santa Monica-based biotech firm was approved Wednesday for adults with non-Hodgkin's lymphoma and aggressive types of blood cancer who have tried two treatments of chemotherapy that failed. "In just several decades, gene therapy has gone from being a promising concept to a practical solution to deadly and largely untreatable forms of cancer", said FDA Commissioner Scott Gottlieb, MD, in a statement announcing the approval. CAR-T treatment uses gene therapy techniques not to fix disease-causing genes but to turbocharge T cells, immune system soldiers that cancer can often evade. Patients must be informed of these risks before receiving the therapy. Because of the combination of this process and the innovativeness of the product there were fears until the last minute that the FDA would get cold feet and not approve it, but in the end, thanks to convincing clinical information and the because of the lack of an alternative for the kind of cancer that the product treats, it was approved. This is the first gene therapy to be approved for non-Hodgkin lymphoma (NHL), according to the FDA.

Axi-cel is the second auto T-cell therapy approved by the FDA, with the first, labeled tisagenlecleucel (Kymriah), approved in late August for patients with acute lymphoblastic leukemia, a rare blood cancer commonly affecting children. This newer drug class is not immune to problems, but it also brings great promise for those patients who struggle to beat cancer. We will soon release a comprehensive policy to address how we plan to support the development of cell-based regenerative medicine. "That policy will also clarify how we will apply our expedited programs to breakthrough products that use CAR-T cells and other gene therapies".

However, treatment with Yescarta can cause severe side effects.

Toyota executive: U.S. seeks 'impossible' changes to NAFTA for Mexico, Canada
The three nations will now have until sometime in March 2018 to negotiate rather than the initial cut-off date of end-December. The government has frequently reminded the US that 35 states and nine million American jobs depend on trade with Canada.

To start, a doctor removes some white blood cells, the part of our body's immune system responsible for combatting infections and foreign substances, from a patient. Hospitals and their associated clinics that dispense axicabtagene ciloleucel must be specially certified. "Together, Gilead and Kite will accelerate studies of auto T therapy in multiple blood cancers and advance other cell therapy approaches for solid tumors, with the goal of helping patients with diverse cancers benefit from this new era of personalized cancer therapy". Kite expects to certify 16 centers quickly and is actively working to train more than 30 additional centers, with an eventual target of 70 to 90 centers across the United States.

Gilead Sciences Inc.'s stock rose Thursday morning after the biotech company's Kite Pharma unit gained federal approval for its flagship cell-treatment therapy for adults with advanced lymphoma.

For more on what role pharmacists can play for patients with lymphoma, view the video below.

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