The US may soon approve a cancer drug that is 100 percent effective

A promising cancer drug called dostarlimab is one step closer to widespread availability. The FDA has granted it Breakthrough Therapy designation, which, if successful, will speed its entry into the market, writes New Atlas.

Photo: Kheng Ho Toh | Dreamstime.com

In June, remarkable results from a trial of dorstarlimab (brand name Jemperli) were reported in The New England Journal of Medicine. Dorstarlimab, an antibody that blocks the programmed death receptor 1 (PD-1), completely destroyed colorectal cancer tumors without the need for surgery, radiation, or chemotherapy.

(Programmed death receptor 1 (PD-1) is a protein found on the surface of some immune system cells, especially T-lymphocytes. It plays a key role in regulating the body's immune response, particularly in preventing the immune system from becoming overly active and damaging the body's own tissues. PD-1 is part of a complex immune control system known as immune checkpoints.

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PD-1 and PD-L1 inhibitors (such as pembrolizumab and nivolumab) are used as immunotherapy to treat various types of cancer. These drugs block the interaction of PD-1 with PD-L1/PD-L2, which restores the activity of T cells and allows them to attack tumor cells. – ed.)

Effective immunotherapy could change the lives of patients with colorectal cancer, as current treatments often result in a number of negative consequences for survivors, including loss of fertility and urinary incontinence.

The drug will help change the treatment paradigm for patients with locally advanced dMMR/MSI-H rectal cancer who face long-term adverse effects on quality of life, said Hesham Abdulla, senior vice president, research and development, GlaxoSmithKline (GSK.

Breakthrough therapy designation is intended to speed up the introduction of new drugs that treat serious conditions when there is no other comparable treatment. As of June 2024, the FDA had received 1516 requests for this designation, and only 587 had been approved. This is consistent with previous years, during which about 30% to 40% of requests were approved.

(Breakthrough Therapy Designation (BTD) is a special designation given by the U.S. Food and Drug Administration (FDA) to drugs or treatments that treat serious or life-threatening diseases. This designation indicates that preliminary clinical trial data show that a new treatment is significantly better than existing treatments. – approx.)

Dostarlimab has been under the scrutiny of oncologists since it was tested in patients with rectal cancer at Memorial Sloan-Kettering Cancer Center. It eradicated the patients' tumors and they did not have any recurrences.

After initially reporting 24 patients, MSK updated the results to include data from 42 participants in the drug trial.

"All participants in the clinical trial are doing great," said gastroenterologist Andrea Cercek of MSK. "So far, 42 people have completed the treatment, and none of them have any signs of the disease. The side effects were quite mild and well tolerated.

“This new treatment has also proven to be very effective,” she added. “Most people in the trial have been cancer-free for at least a year, and the original participants have been healthy for up to four years and continue to be so. The success rate remains 100 percent.”

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The Breakthrough designation is the second FDA designation for dostarlimab, which treats dMMR/MSI-H colorectal cancer. The drug received Fast Track designation in January 2023 (a designation granted to speed up the development and approval of drugs to treat serious or life-threatening diseases if they address an unmet medical need). approx.)

The drug will now undergo further testing and rapid review, with the FDA's help speeding up the process. If successful at this stage, it could become widely available about three years earlier than non-breakthrough drugs.

In the United States, approximately 46 people are diagnosed with colorectal cancer each year, and up to 220% of these cases are dMMR/MSI-H cancers.

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