Hormetic Stress Biohacking Type 1 Diabetes CGM

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Photo: Unsplash.com Medical Disclaimer : The content on this blog is purely for informational purposes only. For medical advice, diagnosis and treatment, consult your doctor. The ultimate goal for anyone living with Type 1 Diabetes (T1D) is stability. You want fewer spikes, fewer crashes, and more time spent in your target blood sugar range. Read more on blood sugar spike . For years, standard medical advice focused purely on matching insulin doses to carbohydrate intake. While this foundational math is necessary, it often leaves people riding a frustrating blood sugar roller coaster. Today, a new wave of tech-savvy individuals is looking beyond the traditional playbook. They are combining the principles of biohacking, the physiological benefits of hormetic stress, and the real-time data of Continuous Glucose Monitors (CGMs) to transform how they manage their health. This approach does not replace insulin. Instead, it aims to make the body more resilient, predictable, and res...
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FDA approves first CAR T Cell therapy for marginal zone lymphoma in the U.S.

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The U.S. Food and Drug Administration (FDA) has approved a new indication for Breyanzi (Lisocabtagene maraleucel) as the first Chimeric Antigen Receptor (CAR) T-cell therapy in the U.S. for treatment of adults with marginal zone lymphoma (MZL) who have failed treatment with or relapsed after two or more prior lines of therapy.

Breyanzi is a Chimeric Antigen Receptor (CAR) T-cell therapy that genetically engineers a patient's own T-cells to target and kill cancers.

The "approval represents a major advancement in precision medicine, essentially turning the patient's immune system into a more effective tool to treat MZL," Vinay Prasad, M.D., M.P.H., Chief Medical and Scientific Officer and Director of FDA's Center for Biologics Evaluation and Research.

"The FDA continues to optimize its regulatory authority to expand treatment options in the fight against cancer."

Marginal zone lymphoma (MZL) is a rare slow-growing cancer of the lymphomatic system. It presents about 7 percent of all B-cell non-Hodgkin lymphoma, with approximately 7,460 new cases occurring every year in the U.S. population, said FDA.

Patients with MZL who failed treatment or relapsed following treatment with upfront therapy have decreased survival.

The "approval reflects the FDA's continuing commitment to advance cell therapies to meet the needs of patients with rare cancer," said Vijay Kumar M.D., Acting Director, Office of Therapeutic Products in the FDA's Center for Biologics Evaluation and Research.

"In granting approval, FDA took into consideration the high and durable response rate following a one-time treatment in patients with MZL, almost half of whom had either progression within two years of diagnosis or had refractory disease."

The safety and effectiveness of Breyanzi were evaluated in an open-label, multi-center, single-arm trial in adults with relapsed or refractory MZL who had received at least two or more lines of systemic therapy or who relapsed after hematopoietic stem cell transplant (HSCT).

Study participants underwent leukapheresis, a process to collect a patient's own immune cells to manufacture Breyanzi.

Patients received a single dose of Breyanzi two to seven days following the completion of preparatory chemotherapy to deplete recipient's lymphocytes, a type of white blood cells, said FDA.

Among the 77 patients who underwent leukapheresis, 66 patients received the study specified single infusion of Breyanzi, of which 99.5 percent of patients experienced a response to treatment and 62.1 percent of patients had complete response without signs of marginal zone lymphoma on imaging scans. 

The responses were durable after a median follow up of 21.6 months.

The most common adverse reactions cytomine release syndrome (CRS), diarrhea, fatigue, musculoskeletal pain, and headache.

The FDA granted traditional approval of Breyanzi to Juno Therapeutics, Inc.

SOURCE: U.S. FDA

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