The FDA has approved the use of the Nevro Corporation’s advanced spinal cord stimulator (SCS), which uses AI to individualise treatment for the specific patient to treat their individual chronic pain.
Nevro’s Senza HFX iQ device is said to “learn from patients” as they continue to use the device, allowing it to create customised algorithms to treat the patient’s pain, specifically chronic back pain, leg pain and pain from diabetic neuropathy.
The algorithm is designed to gradually adjust pain management, after accounting for patient input and medical data, including factors such as pain scores, activity levels and pain medication use. The patient will also be able to adjust the pain management programmes through a smartphone app linked to the device. The surgically implanted SCSs are often considered the last resource in chronic pain management, for patients who do not respond to other pain management strategies. They emit low levels of electricity to reduce the intensity of the patient’s pain signals.
Keith Grossman, Chair and CEO of Nevro, said in a news release: “HFX iQ is designed to improve the consistency of pain relief and is the only SCS system that truly personalises care. […] Pain is variable from patient to patient and over time. Using the Big Data from our HFX Cloud patient database, our unique HFX Algorithm was developed to identify those programmes where patients have been more likely to get relief in the real world. HFX iQ takes direct input from each patient on their pain and quality of life measures to get smarter over time and recommend programme changes.”
APPROVALS
EC approves CAR T cell therapy for B cell lymphoma
Kite, a global biopharmaceutical company based in California, has announced that the European Commission (EC) has approved its cell therapy Yescarta ®for B cell lymphoma patients.
The approval is based on results from a phase 3 ZUMA-7 trial, the largest and longest Chimeric Antigen Receptor (CAR) T cell therapy versus standard of care (SOC) study in this patient population.
Yescarta is now the first CAR T cell therapy approved for patients in Europe who don’t respond to first-line treatment.
Typically, 60% of newly diagnosed large B cell lymphoma (LBCL) patients, including those with diffuse large B cell lymphoma (DLBCL), will respond favourably to initial treatment, however the remainder will either have no reaction, or relapse. Yescarta will be used to treat patients with DLBCL and high-grade B cell lymphoma (HGBCL), who relapse within 12 months or who don’t react to chemo-immunotherapy.
Christi Shaw, CEO, Kite stated: “We are very proud to announce Kite’s fifth approved indication in Europe in our continued commitment to the research and delivery of cell therapies with curative potential to patients who might benefit around the world. Today’s approval marks an important step by providing patients in Europe this option of CAR T cell therapy earlier in their treatment journey.”
Professor John Gribben, Professor of Medical Oncology at the Cancer Research UK Barts Centre, London, added, “This approval marks a major shift in the treatment of LBCL when initial treatment has failed. In ZUMA-7, treatment with axicabtagene ciloleucel resulted in an overall better outcome for patients than standard of care, especially in terms of event-free survival, marking a new era for treatment earlier in the disease pathway for more patients. The ZUMA-7 data has also broadened our understanding of this CAR T cell therapy, allowing us to better manage or prevent side effects, which is important as it moves earlier in the treatment pathway and for older patients and those with medical conditions for whom the standard of care might have been difficult.”
APPROVALS
AstraZeneca’s liver cancer treatment gets FDA approval
Cambridge, UK-based pharmaceutical company AstraZeneca has announced that its Imjudo treatment for adults with unresectable liver cancer has gained FDA approval. The treatment is to be used alongside Imfinzi, and showed promising results in its phase 3 trial.
Patients treated with Imjudo, in combination with Imfinzi, saw a 22% reduction in the risk of death when compared with those treated with sorafenib, a commonly used oncology drug. The trial showed that 31% of patients treated with the Imjudo-Imfinzi combination were alive after three years, whereas only 20% of those treated with sorafenib were still alive after the same period of time.
The combination Imjudo-Imfinzi treatment includes taking one 300 milligram dose of Imjudo, an anti-CTLA-4 antibody, along with a 1,500 milligram dose of Imfinzi, an anti-PD-L1 antibody, then a dose of Imfinzi every four weeks. Both CTLA-4 and PD-L1 are proteins that slow the body’s immune response, binding to certain other proteins and stopping T cells from killing other cells, such as cancer cells. By stopping CTLA-4 and PD-L1 from binding to these other proteins, the T cells are more able to kill the cancer cells.
Dave Frederickson, Executive Vice President of the Oncology Business Unit, commented: “With this first regulatory approval for Imjudo, patients with unresectable liver cancer in the US now have an approved dual immunotherapy treatment regimen that harnesses the potential of CTLA-4 inhibition in a unique combination with a PD-L1 inhibitor to enhance the immune response against their cancer.”