{"id":27045,"date":"2021-05-12T12:00:00","date_gmt":"2021-05-12T12:00:00","guid":{"rendered":"https:\/\/www.cancer.gov\/news-events\/cancer-currents-blog\/2021\/sacituzumab-govitecan-tnbc-regular-approval"},"modified":"2024-11-03T15:14:56","modified_gmt":"2024-11-03T15:14:56","slug":"sacituzumab-govitecan-earns-full-approval-for-triple-negative-breast-cancer","status":"publish","type":"post","link":"https:\/\/ogkologos.com\/en\/sacituzumab-govitecan-earns-full-approval-for-triple-negative-breast-cancer\/","title":{"rendered":"Sacituzumab Govitecan Earns Full Approval for Triple-Negative Breast Cancer"},"content":{"rendered":"
<\/div>\n

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In triple-negative breast cancer (TNBC), tumor cells don’t have estrogen receptors (ER), progesterone receptors (PR), or large amounts of the HER2 protein on their surface.<\/p>\n

Credit: National Cancer Institute<\/p>\n<\/div>\n<\/figcaption><\/figure>\n<\/div>\n

On April 7, the Food and Drug Administration (FDA) granted regular approval to sacituzumab govitecan (Trodelvy) for some patients with triple-negative breast cancer (TNBC). The agency\u2019s action follows last year\u2019s accelerated approval of the drug<\/a>. <\/p>\n

The treatment is approved for people with triple-negative breast cancer that is locally advanced<\/a> or has spread to other parts of the body and can\u2019t be removed by surgery. Patients must have received two or more breast cancer therapies, including one for metastatic<\/a> disease, before being treated with sacituzumab<\/a>.<\/p>\n

Promising results from a small study led to the accelerated approval in April 2020. FDA has now upgraded to a regular approval based on findings from a much larger confirmatory clinical trial<\/a> that showed the drug improved how long patients lived compared with standard chemotherapy treatments<\/a>.<\/p>\n

\u201cThis approval validates sacituzumab as an effective new treatment for patients with triple-negative breast cancer,\u201d said Jennifer Matro, M.D., a breast cancer doctor at University of California San Diego Health. <\/p>\n

It \u201cprovides a much-needed option for patients who have not responded to other therapies,\u201d she added.<\/p>\n

Sacituzumab consists of an antibody<\/a> coupled to a more potent form of the chemotherapy drug irinotecan (Camptosar)<\/a>. The antibody binds to breast cancer cells, delivering the chemotherapy directly to those cells. <\/p>\n

\u201cHistorically, the only treatments available for triple-negative breast cancer have been chemotherapies, which are not specifically targeted to the cancer and tend to have more side effects,\u201d Dr. Matro explained. <\/p>\n

More than 500 people, all of whom had triple-negative breast cancer that had come back after at least two different chemotherapy treatments, participated in the trial. Among the study participants, 79% were White and 12% were Black. <\/p>\n

Twelve percent of patients in the trial had breast cancer that had spread to the brain (what\u2019s known as brain metastases). Nearly half of patients with metastatic triple-negative breast cancer develop brain metastases, which can limit their physical and cognitive abilities, Dr. Matro explained. People with brain metastases often don\u2019t live as long as people without them. <\/p>\n

All participants were randomly assigned to receive either sacituzumab or chemotherapy (one of four specific drugs, as selected by their doctor). Sacituzumab is given as an infusion through a vein in the arm.<\/p>\n\n\n\n\n\n
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Measure<\/h5>\n<\/td>\n
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Sacituzumab group<\/h5>\n<\/td>\n
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Chemotherapy group<\/h5>\n<\/td>\n<\/tr>\n
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Months lived without cancer progression (median progression-free survival)<\/span><\/span><\/span><\/p>\n<\/td>\n

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4.8<\/p>\n<\/td>\n

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1.7<\/p>\n<\/td>\n<\/tr>\n

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Months lived overall (median overall survival)<\/span><\/span><\/span><\/p>\n<\/td>\n

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11.8<\/p>\n<\/td>\n

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6.9<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Among all participants, those who received sacituzumab lived a median of 3 months longer without their disease progressing than those who received chemotherapy. And patients in the sacituzumab group lived a median of nearly 5 months longer than those in the chemotherapy group. <\/p>\n

\u201cEffective treatments for patients with brain metastases are desperately needed, and to have a clinical trial not only include patients with brain metastases but also demonstrate improvements in disease progression<\/a> and survival is an important breakthrough for these patients,\u201d Dr. Matro noted. <\/p>\n

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Sacituzumab is made of an antibody (green) linked to a potent chemotherapy drug called SN-38 (pink circles). <\/p>\n

Credit: Gilead Sciences, Inc.<\/p>\n<\/div>\n<\/figcaption><\/figure>\n<\/div>\n

Among participants without brain metastases, sacituzumab measurably shrank tumors in 35% of those who received it, according to trial results published April 22 in the New England Journal of Medicine<\/em>. In comparison, chemotherapy measurably shrank tumors in only 5% of patients without brain metastases. For patients without brain metastases, sacituzumab was more effective than chemotherapy regardless of a patient\u2019s age, race, and number or type of previous therapies received. <\/p>\n

The most common side effects of sacituzumab were low white blood cell counts (neutropenia<\/a>), diarrhea, and nausea. In both the sacituzumab and chemotherapy groups, 5% of patients stopped the treatment because of side effects.<\/p>\n

The FDA approval comes with a warning for severe or life-threatening neutropenia and severe diarrhea. The agency recommends periodically monitoring patients for these side effects during treatment. Both neutropenia and diarrhea can be treated with additional medicines. <\/p>\n

It\u2019s important for patients and their doctors to discuss where sacituzumab may fit into their treatment plan<\/a>, Dr. Matro noted, particularly as additional data emerge for immunotherapies in select patients with triple-negative breast cancer.<\/p>\n

Source<\/a><\/p>","protected":false},"excerpt":{"rendered":"

May 12, 2021, by NCI Staff In triple-negative breast cancer (TNBC), tumor cells don’t have estrogen receptors (ER), progesterone receptors (PR), or large amounts of the HER2 protein on their surface. Credit: National Cancer Institute On April 7, the Food and Drug Administration (FDA) granted regular approval to sacituzumab govitecan (Trodelvy) for some patients with […]<\/p>\n","protected":false},"author":2,"featured_media":27046,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"footnotes":""},"categories":[5137],"tags":[],"class_list":["post-27045","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-world-news"],"_links":{"self":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/27045","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/comments?post=27045"}],"version-history":[{"count":1,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/27045\/revisions"}],"predecessor-version":[{"id":43809,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/27045\/revisions\/43809"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/media\/27046"}],"wp:attachment":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/media?parent=27045"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/categories?post=27045"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/tags?post=27045"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}