{"id":2886,"date":"2022-10-25T13:15:26","date_gmt":"2022-10-25T16:15:26","guid":{"rendered":"https:\/\/www.zalikafarmaceutica.com\/?p=2886"},"modified":"2024-12-09T11:01:01","modified_gmt":"2024-12-09T14:01:01","slug":"fda-approves-tremelimumab-plus-durvalumab-for-adult-patients-with-unresectable-hcc","status":"publish","type":"post","link":"https:\/\/www.zalikafarmaceutica.com\/pt\/2022\/10\/25\/fda-approves-tremelimumab-plus-durvalumab-for-adult-patients-with-unresectable-hcc\/","title":{"rendered":"FDA APPROVES TREMELIMUMAB PLUS DURVALUMAB FOR ADULT PATIENTS WITH UNRESECTABLE HCC"},"content":{"rendered":"

\"Get<\/a><\/p>\n

On October 24, the U.S. Food and Drug Administration (FDA) approved\u00a0tremelimumab (Imjudo) in combination with durvalumab (Imfinzi) for the treatment of adult patients with unresectable hepatocellular carcinoma (HCC), the most common type of liver cancer. The novel dose and schedule of the combination, which includes a single dose of the anti\u2013CTLA-4 antibody\u00a0tremelimumab at\u00a0300 mg added to the anti\u2013PD-L1 antibody\u00a0durvalumab at\u00a01,500 mg followed by\u00a0durvalumab\u00a0<\/em>every 4 weeks,<\/em>\u00a0is called the STRIDE regimen (single tremelimumab, regular-interval durvalumab).<\/p>\n

HIMALAYA Trial<\/strong><\/p>\n

The FDA approval was based on positive results from the phase III HIMALAYA trial. In HIMALAYA, patients treated with the combination of tremelimumab and durvalumab experienced a 22% reduction in the risk of death vs those receiving sorafenib (hazard ratio [HR] = 0.78, 95% confidence interval = 0.66\u20130.92 P = .0035). Results published by Abou-Alfa et al in\u00a0\u00a0The New England Journal of Medicine Evidence<\/a><\/em><\/span>\u00a0showed that an estimated 31% of patients treated with the combination were still alive after 3 years, with 20% of patients treated with sorafenib still alive at the same duration of follow-up.<\/p>\n

Ghassan Abou-Alfa, MD, MBA<\/strong>, attending physician at Memorial Sloan Kettering Cancer Center and principal investigator of the HIMALAYA trial, said, \u201cPatients with unresectable liver cancer are in need of well-tolerated treatments that can meaningfully extend overall survival. In addition to this regimen demonstrating a favorable 3-year survival rate in the HIMALAYA trial, safety data showed no increase in severe liver toxicity or bleeding risk for the combination \u2013 important factors for patients with liver cancer who also have advanced liver disease.\u201d<\/p>\n

Andrea Wilson Woods<\/strong>, President & Founder, Blue Faery: The Adrienne Wilson Liver Cancer Foundation, said: \u201cIn the past, patients living with liver cancer had few treatment options and faced poor prognosis. With today\u2019s approval, we are grateful and optimistic for new, innovative therapeutic options. These new treatments can improve long-term survival for those living with unresectable HCC, the most common form of liver cancer. We appreciate the patients, their families, and the broader liver cancer community who continue to fight for new treatments and advocate for others.\u201d<\/p>\n

The safety profiles of the combination of\u00a0tremelimumab\u00a0<\/em>and\u00a0durvalumab and for\u00a0durvalumab alone were consistent with the known profiles of each medicine, and no new safety signals were identified.<\/p>\n

Regulatory applications for\u00a0tremelimumab\u00a0in combination with\u00a0durvalumab are currently under review in Europe, Japan, and several other countries for the treatment of patients with advanced liver cancer based on the HIMALAYA results.<\/p>\n

Read the original article<\/a><\/span>
\n
\nO conte\u00fado deste post n\u00e3o foi revisado pela Sociedade Americana de Oncologia Cl\u00ednica, Inc. (ASCO\u00ae) e n\u00e3o reflete necessariamente as ideias e opini\u00f5es da ASCO\u00ae.
\n<\/em><\/p>","protected":false},"excerpt":{"rendered":"

On October 24, the U.S. Food and Drug Administration (FDA) […]<\/p>","protected":false},"author":1,"featured_media":2887,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[1],"tags":[],"yoast_head":"\nFDA APPROVES TREMELIMUMAB PLUS DURVALUMAB FOR ADULT PATIENTS WITH UNRESECTABLE HCC - Zalika Farmac\u00eautica<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.zalikafarmaceutica.com\/pt\/2022\/10\/25\/fda-approves-tremelimumab-plus-durvalumab-for-adult-patients-with-unresectable-hcc\/\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA APPROVES TREMELIMUMAB PLUS DURVALUMAB FOR ADULT PATIENTS WITH UNRESECTABLE HCC - Zalika Farmac\u00eautica\" \/>\n<meta property=\"og:description\" content=\"On October 24, the U.S. Food and Drug Administration (FDA) […]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.zalikafarmaceutica.com\/pt\/2022\/10\/25\/fda-approves-tremelimumab-plus-durvalumab-for-adult-patients-with-unresectable-hcc\/\" \/>\n<meta property=\"og:site_name\" content=\"Zalika Farmac\u00eautica\" \/>\n<meta property=\"article:published_time\" content=\"2022-10-25T16:15:26+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-12-09T14:01:01+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.zalikafarmaceutica.com\/wp-content\/uploads\/2022\/10\/Zalika-Farmaceutica-FDA-Approves-Tremelimumab-Plus-Durvalumab-for-Adult-Patients.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1024\" \/>\n\t<meta property=\"og:image:height\" content=\"768\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Escrito por\" \/>\n\t<meta name=\"twitter:data1\" content=\"\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. tempo de leitura\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutos\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.zalikafarmaceutica.com\/2022\/10\/25\/fda-approves-tremelimumab-plus-durvalumab-for-adult-patients-with-unresectable-hcc\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.zalikafarmaceutica.com\/2022\/10\/25\/fda-approves-tremelimumab-plus-durvalumab-for-adult-patients-with-unresectable-hcc\/\"},\"author\":{\"name\":\"\",\"@id\":\"\"},\"headline\":\"FDA APPROVES TREMELIMUMAB PLUS DURVALUMAB FOR ADULT PATIENTS WITH UNRESECTABLE HCC\",\"datePublished\":\"2022-10-25T16:15:26+00:00\",\"dateModified\":\"2024-12-09T14:01:01+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.zalikafarmaceutica.com\/2022\/10\/25\/fda-approves-tremelimumab-plus-durvalumab-for-adult-patients-with-unresectable-hcc\/\"},\"wordCount\":444,\"publisher\":{\"@id\":\"https:\/\/www.zalikafarmaceutica.com\/#organization\"},\"articleSection\":[\"News\"],\"inLanguage\":\"pt-BR\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.zalikafarmaceutica.com\/2022\/10\/25\/fda-approves-tremelimumab-plus-durvalumab-for-adult-patients-with-unresectable-hcc\/\",\"url\":\"https:\/\/www.zalikafarmaceutica.com\/2022\/10\/25\/fda-approves-tremelimumab-plus-durvalumab-for-adult-patients-with-unresectable-hcc\/\",\"name\":\"FDA APPROVES TREMELIMUMAB PLUS DURVALUMAB FOR ADULT PATIENTS WITH UNRESECTABLE HCC - 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