{"id":46686,"date":"2024-07-02T07:00:00","date_gmt":"2024-07-02T07:00:00","guid":{"rendered":"http:\/\/f15fdeed46212ea1c1e7205c154790a7"},"modified":"2024-11-03T15:11:49","modified_gmt":"2024-11-03T15:11:49","slug":"fda-grants-traditional-approval-to-selpercatinib-for-ret-fusion-positive-thyroid-cancer","status":"publish","type":"post","link":"https:\/\/ogkologos.com\/en\/fda-grants-traditional-approval-to-selpercatinib-for-ret-fusion-positive-thyroid-cancer\/","title":{"rendered":"FDA Grants Traditional Approval to Selpercatinib for RET Fusion-positive Thyroid Cancer"},"content":{"rendered":"

On 12 June 2024, the US Food and Drug Administration (FDA) granted traditional approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult and paediatric patients 2 years of age and older with advanced or metastatic RET<\/em> fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).<\/p>\n

Selpercatinib received accelerated approval<\/a> for this indication for patients 12 years of age and older in 2020.<\/p>\n

Efficacy was evaluated in LIBRETTO-001 (NCT03157128), a multicentre, open-label, muti-cohort study in 65 patients with RET<\/em> fusion-positive thyroid cancer who were radioactive iodine (RAI)-refractory (if RAI was an appropriate treatment option) and were systemic therapy na\u00efve and patients who were previously treated, in separate cohorts.<\/p>\n

The major efficacy outcome measures were overall response rate (ORR) and duration of response (DoR). The ORR was 85% (95% confidence interval [CI] 71%, 94%) in the 41 previously treated patients and 96% (95% CI 79%, 100%) in the 24 systemic therapy na\u00efve patients. Median DoR was 26.7 months (95% CI 12.1, not evaluable [NE]) in the previously treated patients and NE (95% CI 42.8, NE) in the systemic therapy na\u00efve patients.<\/p>\n

Supportive evidence included ORR and DoR data from 10 paediatric and young adult patients with RET<\/em> fusion-positive thyroid cancer treated in Study LIBRETTO-121 (J2G-OX-JZJJ; NCT03899792), an international, single-arm, multi-cohort study of selpercatinib in paediatric and young adult patients with advanced RET<\/em>-altered solid tumours. The ORR was 60% (95% CI 26%, 88%), and 83% had an observed DoR \u2265 12 months.<\/p>\n

The most common adverse reactions (\u226525%) were oedema, diarrhoea, fatigue, dry mouth, hypertension, abdominal pain, constipation, rash, nausea, and headache. The most common Grade 3 or 4 laboratory abnormalities (\u22655%) were decreased lymphocytes, increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), decreased sodium, and decreased calcium.<\/p>\n

The recommended selpercatinib dose for paediatric patients 2 to less than 12 years of age is based on body surface area. It is based on weight for patients 12 years of age and older.<\/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 breakthrough designation and orphan drug designation.<\/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 12 June 2024, the US Food and Drug Administration (FDA) granted traditional approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult and paediatric patients 2 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). Selpercatinib […]<\/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-46686","post","type-post","status-publish","format-standard","hentry","category-world-news"],"_links":{"self":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/46686","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=46686"}],"version-history":[{"count":1,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/46686\/revisions"}],"predecessor-version":[{"id":46987,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/46686\/revisions\/46987"}],"wp:attachment":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/media?parent=46686"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/categories?post=46686"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/tags?post=46686"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}