{"id":8032,"date":"2024-01-18T11:20:11","date_gmt":"2024-01-18T05:50:11","guid":{"rendered":"https:\/\/indianpharmanetwork.co.in\/medicines\/?p=8032"},"modified":"2024-01-18T11:20:11","modified_gmt":"2024-01-18T05:50:11","slug":"fda-approval-updates-on-neratinib","status":"publish","type":"post","link":"https:\/\/indianpharmanetwork.co.in\/medicines\/breast-cancer\/fda-approval-updates-on-neratinib\/","title":{"rendered":"FDA Approval Updates on Neratinib"},"content":{"rendered":"

Neratinib for extended adjuvant treatment of early stage HER2-positive breast cancer<\/h3>\n

Neratinib is approved by the U.S. Food and Drug Administration for extended adjuvant treatment of early stage HER2-overexpressed\/amplified breast cancer adult patients as adjuvant after trastuzumab-based therapy.<\/p>\n

The ExteNET trial was a multicenter, randomized, double-blind, placebo-controlled trial of neratinib following adjuvant trastuzumab treatment that evaluated women (n=2,840) with early-stage HER2-positive breast cancer. Patients were randomized to receive either neratinib (n=1420) or placebo (n=1420) for one year within two years of completing adjuvant trastuzumab.<\/p>\n

The invasive disease-free survival (iDFS; time between the randomization date to the first occurrence of invasive recurrence (local\/regional, ipsilateral or contralateral breast cancer), distant recurrence, or death from any cause, within two years and 28 days of follow-up) was the major efficacy outcome measure. The iDFS was 94.2% in the neratinib group compared to 91.9% in the placebo group (HR 0.66; 95% CI: 0.49, 0.90, p=0.008) after two years.<\/p>\n

The recommended dose of neratinib is 240 mg PO OD with food continuously for one year. Diarrhea was \u00a0seen in 16.8% of neratinib-treated patients and this was the most common adverse reaction leading to discontinuation. As such, antidiarrheal prophylaxis should be started with the first neratinib dose and given during the first 2 cycles (56 days) of treatment and as required thereafter. Drug discontinuation in 1.7% of neratinib-treated patients was also seen due to hepatotoxicity or increases in liver transaminases.<\/p>\n

Full prescribing information is available at:\u00a0https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2017\/208051s000lbl.pdf<\/a><\/p>\n

Abemaciclib as initial therapy for HR-positive, HER2-negative metastatic breast cancer<\/h3>\n

Abemaciclib is now US FDA approved for use when combined with an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.<\/p>\n

\"\"<\/p>\n

The results of the MONARCH 3, a randomized (2:1), double-blinded, placebo-controlled, multicenter clinical trial in postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer was the basis of this approval.<\/p>\n

Patients (n= 493) were randomized to abemaciclib 150 mg or placebo, PO BID along with the physician\u2019s choice of either letrozole or anastrozole. 28.2 months (95% CI: 23.5, Not reached) was the estimated median progression-free survival (PFS) (RECIST 1.1) for patients receiving abemaciclib as compared to 14.8 months (95% CI: 11.2, 19.2) for the \u00a0placebo group (HR 0.540; 95% CI: 0.418, 0.698; p<>). 150 mg PO BID, with or without food is the recommended starting dose of abemaciclib in combination with an aromatase inhibitor.<\/p>\n

Full prescribing information is available at:\u00a0https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/208855s000lbl.pdf<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Neratinib for extended adjuvant treatment of early stage HER2-positive breast cancer Neratinib is approved by the U.S. Food and Drug Administration for extended adjuvant treatment of early stage HER2-overexpressed\/amplified breast cancer adult patients as adjuvant after trastuzumab-based therapy. The ExteNET trial was a multicenter, randomized, double-blind, placebo-controlled trial of neratinib following adjuvant trastuzumab treatment that […]<\/p>\n","protected":false},"author":2,"featured_media":8034,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"categories":[3],"tags":[],"class_list":["post-8032","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-breast-cancer"],"_links":{"self":[{"href":"https:\/\/indianpharmanetwork.co.in\/medicines\/wp-json\/wp\/v2\/posts\/8032","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/indianpharmanetwork.co.in\/medicines\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/indianpharmanetwork.co.in\/medicines\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/indianpharmanetwork.co.in\/medicines\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/indianpharmanetwork.co.in\/medicines\/wp-json\/wp\/v2\/comments?post=8032"}],"version-history":[{"count":1,"href":"https:\/\/indianpharmanetwork.co.in\/medicines\/wp-json\/wp\/v2\/posts\/8032\/revisions"}],"predecessor-version":[{"id":8035,"href":"https:\/\/indianpharmanetwork.co.in\/medicines\/wp-json\/wp\/v2\/posts\/8032\/revisions\/8035"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/indianpharmanetwork.co.in\/medicines\/wp-json\/wp\/v2\/media\/8034"}],"wp:attachment":[{"href":"https:\/\/indianpharmanetwork.co.in\/medicines\/wp-json\/wp\/v2\/media?parent=8032"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/indianpharmanetwork.co.in\/medicines\/wp-json\/wp\/v2\/categories?post=8032"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/indianpharmanetwork.co.in\/medicines\/wp-json\/wp\/v2\/tags?post=8032"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}