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Until now, people with unresectable triple negative bad cancer had a treatment option: chemotherapy. But this month, the US Food and Drug Administration (FDA) has fast-tracked the first immunotherapy treatment for bad cancer. It combines the drug atezolizumab (Tecentriq) with a form of chemotherapy.
This development is great news because the drug has obtained the first phase 3 positive trial of an immunotherapy drug intended to treat bad cancer. The treatment was also the first to show a substantial survival benefit for people with triple negative bad cancer, one of the most aggressive forms of the disease.
In the future, this opens the field to a vast development program, Dr. Peter Schmid, PhD, one of the researchers at Queen Mary University in London, told Healthline.
Tecentriq is the brand name of the drug Atezolizumab immunotherapy. It has already been approved to treat specific types of cancers of the urine and lung.
A study published last fall in the New England Journal of Medicine found that treatment prolongs progression-free survival, which is a period of time during which cancer does not worsen. Those who used the drug had a median progression-free survival of 7.4 months, compared with 4.8 months for those who received only chemotherapy with placebo.
"This is the first time that immunotherapy works in a cancer that is so difficult to treat," Schmid said in a statement.
Schmid said more research is needed to see if the drug could work on other types or in earlier stages of bad cancer.
Atezolizumab is an antibody that binds to a PD-L1 protein, a protein of cancer cells, explained Leisha Emens, PhD, a professor at the Hillman Cancer Center at the University of Pittsburgh Medical Center, who participated in the test.
This protein is expressed almost exclusively with immune cells in a tumor. The drug binds to the PD-L1 protein and releases the immune cells from the tumor so they can fight cancer. Chemotherapy is part of the treatment because it can reduce the tumor burden that the immune system has to fight and strengthen the immune cells' ability to attack cancer.
"With this approval, we now have a targeted agent for the treatment of triple negative bad cancer, and this targeted agent engages the immune system," said Emens.
"People who use and respond to this drug combination may benefit from a longer response to treatment because of the activation of the immune system and the ability of the immune response to persist," she added.
But this new drug has a high price, according to the Associated Press. The newspaper reported that atezolizumab cost about $ 13,400 a month.
Dr. Amy Tiersten, a bad oncologist at the Dubin Breast Center at the Mount Sinai Tisch Cancer Institute in New York, was pleased with the drug's approval and said it should be covered by insurance.
FDA's fast-track approval is granted for certain drugs that address critical illness and address an unmet need. The manufacturer of the drug is still required to conduct additional tests and should submit more results by next September. Based on these findings, the drug could get traditional approval.
When the growth of bad cancer cells is not triggered by estrogen, progesterone or human epidermal growth factor (HER2), it is called triple negative bad cancer. This type of bad cancer is considered aggressive with a poor prognosis.
It does not respond to hormonal cancer treatments that have improved survival rates for people with other forms of the disease. However, it responds to chemotherapy, but cancer cells can develop resistance to chemotherapy agents. The treatment can also be very difficult for the patient as it destroys healthy cells and cancer cells.
Triple negative bad cancer is most likely to affect Hispanic and African-American women, as well as people with the BRCA1 gene mutation. It can develop in women in their forties and fifties.
About 15% of bad cancers are triple negative, the Reports from the National Breast Cancer Foundation.
About a fifth of people with triple negative bad cancer have PD-L1 protein, which is the target of atezolizumab.
The US Food and Drug Administration (FDA) has granted accelerated approval for the first immunotherapy treatment for bad cancer. It combines the drug atezolizumab (Tecentriq) with a form of chemotherapy.
A study published last fall in the New England Journal of Medicine found that treatment prolongs progression-free survival, which is a period of time during which cancer does not worsen. Those who used the drug had a median progression-free survival of 7.4 months, compared with 4.8 months for those who received only chemotherapy with placebo.
It would cost $ 13,400 a month.
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