{"id":46621,"date":"2024-05-08T07:10:00","date_gmt":"2024-05-08T07:10:00","guid":{"rendered":"http:\/\/fe80bbca7cc1f3f946cd94457c41e7ff"},"modified":"2024-11-03T15:11:51","modified_gmt":"2024-11-03T15:11:51","slug":"fda-approves-tisotumab-vedotin-tftv-for-recurrent-or-metastatic-cervical-cancer","status":"publish","type":"post","link":"https:\/\/ogkologos.com\/en\/fda-approves-tisotumab-vedotin-tftv-for-recurrent-or-metastatic-cervical-cancer\/","title":{"rendered":"FDA Approves Tisotumab Vedotin-tftv for Recurrent or Metastatic Cervical Cancer"},"content":{"rendered":"

On 29 April 2024, the US Food and Drug Administration (FDA) granted traditional approval to tisotumab vedotin-tftv (Tivdak, Seagen Inc.  [now a part of Pfizer Inc.]) for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Tisotumab vedotin-tftv previously received<\/a> accelerated approval for this indication.<\/p>\n

Efficacy was evaluated in innovaTV 301 (NCT04697628), an open-label, active-controlled, multicentre, randomised study that enrolled 502 patients with recurrent or metastatic cervical cancer who had received one or two prior systemic regimens, including chemotherapy with or without bevacizumab and\/or an anti-PD-(L)1 agent. Patients were excluded if they had active ocular surface disease, any prior episode of cicatricial conjunctivitis or ocular Stevens-Johnson syndrome, Grade \u22652 peripheral neuropathy, or clinically significant bleeding issues or risks.<\/p>\n

Patients were randomised (1:1) to receive either tisotumab vedotin 2 mg\/kg intravenously every 3 weeks or investigator\u2019s choice of chemotherapy consisting of topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed, until unacceptable toxicity or disease progression.<\/p>\n

The major efficacy outcome measure was overall survival (OS). Additional efficacy outcome measures were progression-free survival (PFS) and confirmed objective response rate (ORR) as assessed by the investigator using RECIST v1.1. Median OS was 11.5 months (95% confidence interval [CI] 9.8, 14.9) in the tisotumab vedotin arm and 9.5 months (95% CI 7.9, 10.7) in the chemotherapy arm (hazard ratio [HR] 0.70, 95% CI 0.54, 0.89; p-value = 0.0038). Median PFS was 4.2 months (95% CI 4.0, 4.4) in the tisotumab vedotin arm and 2.9 months (95% CI 2.6, 3.1) for those treated with chemotherapy (HR 0.67, 95% CI 0.54, 0.82; p-value <0.0001). Confirmed ORR was 17.8% (95% CI 13.3, 23.1) and 5.2% (95% CI 2.8, 8.8) in the respective arms (p-value <0.0001). This trial\u2019s results fulfill the post-marketing requirement of the previous accelerated approval.<\/p>\n

The most common adverse reactions (\u226525%), including laboratory abnormalities, were decreased haemoglobin, peripheral neuropathy, conjunctival adverse reactions, increased aspartate aminotransferase, nausea, increased alanine aminotransferase, fatigue, decreased sodium, epistaxis, and constipation.<\/p>\n

The recommended tisotumab vedotin dose is 2 mg\/kg (maximum of 200 mg for patients \u2265100 kg) administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity.<\/p>\n

This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA\u2019s assessment.<\/p>\n

This application was granted priority review.<\/p>\n

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA\u2019s MedWatch Reporting System.<\/p>\n

For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact FDA\u2019s Oncology Center of Excellence<\/a> Project Facilitate<\/a>.<\/p>\n

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

On 29 April 2024, the US Food and Drug Administration (FDA) granted traditional approval to tisotumab vedotin-tftv (Tivdak, Seagen Inc.  [now a part of Pfizer Inc.]) for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Tisotumab vedotin-tftv previously received accelerated approval for this indication. Efficacy was evaluated in innovaTV 301 (NCT04697628), an […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"footnotes":""},"categories":[5137],"tags":[],"class_list":["post-46621","post","type-post","status-publish","format-standard","hentry","category-world-news"],"_links":{"self":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/46621","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=46621"}],"version-history":[{"count":1,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/46621\/revisions"}],"predecessor-version":[{"id":47042,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/46621\/revisions\/47042"}],"wp:attachment":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/media?parent=46621"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/categories?post=46621"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/tags?post=46621"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}