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The FDA approves the first immunotherapy regimen for breast cancer

The treatment received accelerated triple-negative breast cancer approval that is locally advanced or metastatic, which cannot be surgically removed and whose cells include a protein called PD-L1. It includes a combination of immunotherapy and chemotherapy: Tecentriq and Abraxane respectively. The FDA's decision comes after an October study published in the New England Journal of Medicine, that the therapy prolonged progression-free survival – how much time in which the patient's cancer did not get worse. In the PD-L1 subset, median progression-free survival for those receiving combination therapy was 7.4 months, compared to 4.8 months for those receiving chemotherapy with placebo, according to the FDA's announcement. The trial was funded by Genentech Inc., the manufacturer of Tecentriq. "This is the first time immunotherapy has worked in such a difficult way to treat cancer, and is a big step forward for these breast cancer patients," says lead student author Dr. Peter Schmid of the Queen Mary University of London in an October statement. [1 9659004] Dr. Otis Brawley, Bloomberg Distinguished Professor of Oncology and Epidemiology at Johns Hopkins University, said the FDA's decision to grant accelerated approval treatment was "the right thing to do" but warned that it is not the end of history. "The FDA has approved it based on progression-free survival with the hope that later … data shows that the treatment really makes women live longer," said Brawley, who was not involved in examining the treatment. This FDA says that it gives accelerating approvals to "drugs that treat serious conditions,…

The treatment received accelerated triple-negative breast cancer approval that is locally advanced or metastatic, which cannot be surgically removed and whose cells include a protein called PD-L1. It includes a combination of immunotherapy and chemotherapy: Tecentriq and Abraxane respectively.

The FDA’s decision comes after an October study published in the New England Journal of Medicine, that the therapy prolonged progression-free survival – how much time in which the patient’s cancer did not get worse. In the PD-L1 subset, median progression-free survival for those receiving combination therapy was 7.4 months, compared to 4.8 months for those receiving chemotherapy with placebo, according to the FDA’s announcement. The trial was funded by Genentech Inc., the manufacturer of Tecentriq.

“This is the first time immunotherapy has worked in such a difficult way to treat cancer, and is a big step forward for these breast cancer patients,” says lead student author Dr. Peter Schmid of the Queen Mary University of London in an October statement. [1

9659004] Dr. Otis Brawley, Bloomberg Distinguished Professor of Oncology and Epidemiology at Johns Hopkins University, said the FDA’s decision to grant accelerated approval treatment was “the right thing to do” but warned that it is not the end of history.

“The FDA has approved it based on progression-free survival with the hope that later … data shows that the treatment really makes women live longer,” said Brawley, who was not involved in examining the treatment.

This FDA says that it gives accelerating approvals to “drugs that treat serious conditions, and which fulfill an unresolved medical need” based on data such as time is on, but cannot directly measure, a clinical benefit. Drug makers are still required to confirm that the drug is beneficial through later trials. If that happens, the drug can get a traditional FDA approval. Otherwise, the agency may decide to withdraw the drug, as has happened before.

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II In this case, the pharmaceutical company is expected to submit a final report describing subsequent findings in September 2020, according to the FDA approval letter to Genentech. .

Tecentriq, the brand name of the immunotherapy drug atezolizumab, was previously approved for the treatment of other specific types of urine and lung cancer.

Breast cancer patients on the newly approved therapy reported mostly side effects such as hair loss, fatigue, nausea, headache and decreased appetite, according to the FDA.

Dr. Larry Norton, Head of Evelyn H. Lauder Breast Center at Memorial Sloan Kettering Cancer Center, told CNN in October that researchers are learning “so much and so fast about other ways to stimulate the immune system” that he predicts an “explosion of well-designed studies that will drive the agenda forward. “

Norton, who did not attend the October study, said” this is just the beginning of immunotherapy for breast cancer “.

Triple-Negative Breast Cancer

About 15% of breast cancer is triple-negative, according to the National Breast Cancer Foundation. The protein PD-L1 can be found in about one fifth of the cancers that research has shown.

Triple-negative breast cancer is likely to affect Latin American and African-American women and those with a BRCA1 gene mutation. It also tends to occur among women in the 40s and 50s.

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“It is particularly tragic that the victims are often young “We have been desperately looking for better treatment options.” When breast cancer cells test negative for estrogen, progesterone or human epidermal growth factor 2 (HER2), it is called a triple-negative breast cancer, so it does not respond to any one. of the available hormonal cancer treatments.

It responds to chemotherapy, but cancer cells can rapidly develop resistance to chemo-drugs so that they can spread to other parts of the body, reducing survival rates.

How it works ?

Cancers have an opportunity to avoid the body’s immune system, which recognizes them as a part of the body, which is where Tecentriq comes in: It is an antibody that attaches to the cancer cell and inactivates the PD-L1 protein, which is responsible for talking about the immune system, “do not attack me.”

Chemotherapy is also needed to “roughly” the outside of the cancer cell, Schmid explained. It allows the newly-grown immune system to recognize and attack the invader.

“We use chemotherapy to tear off the tumor’s” immune protection garment “to reveal it,” Schmid said, “enabling people’s own immune system to access it.”

Norton said in October that “I think expectation is, this will change the standard of care. “

” This is a real progress that will enable us to help more people. “


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