FDA approves new immunotherapy for young leukaemia patients – as it happened

The FDA has approved a new immunotherapy treatment – COVID – for patients suffering from serious and life-threatening infections called CD40+CD33+CD40+CD45+S leukemias and lymphomas.

The treatment is in a class of immunotherapies called chimeric antigen receptor therapies, or CAR T therapies, which harness the body’s own T-cells to target tumors.

The FDA’s nod followed data presented last week during the 28th World Conference on Lung Cancer in Paris. The data showed that COVID was safe and potentially effective in a subset of patients who are resistant to existing therapies.

In some patients the new immunotherapy was as effective as conventional treatment. These patients not only experienced fewer injections but also recorded more long-term responses to the drug, which is over a year away from becoming available for sale in the US.

The interim data is not final and was based on data obtained from 52 patients with CD40+CD33+CD40+CD45+S lymphomas. The following are some key numbers from the report published last week:

This is a critical data point in treating patients with fast-moving cancer. Lymphomas and lung cancers are diseases in which the most common treatments are chemotherapy, surgery, and targeted therapies.

In order to ensure patients’ best chances of survival, the FDA restricted the use of the drug. Lung and skin cancers will not be eligible to be treated with COVID.

With this restriction the hospital, the clinic, the insurance company, and the patient all have to agree.

COVID will not be approved for treatment of all cancers. Lung, breast, kidney, liver, pancreatic, brain, lung/kidney and bone cancers are all excluded.

The FDA also requested that AstraZeneca re-evaluate the drug.

AstraZeneca’s study was designed to collect data for later approval but in order to demonstrate the drug’s effectiveness now it had to conduct two later studies in patients with smaller tumors and those for whom standard treatment is not effective.

The company plans to initiate one trial for patients with solid tumors, including skin and lung cancers, and another for metastatic lymphoma. It will also conduct studies in acute myeloid leukemia. The company also intends to initiate a study to test the effectiveness of the drug in combination with other therapeutic agents to include “both active immune checkpoint inhibition and immunomodulation”.

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