{"id":102744,"date":"2026-08-13T12:21:30","date_gmt":"2026-08-13T12:21:30","guid":{"rendered":"https:\/\/www.europesays.com\/britain\/102744\/"},"modified":"2026-08-13T12:21:30","modified_gmt":"2026-08-13T12:21:30","slug":"nuvalent-deal-delivers-gsks-first-ever-lung-cancer-approval","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/britain\/102744\/","title":{"rendered":"Nuvalent deal delivers GSK\u2019s first-ever lung cancer approval"},"content":{"rendered":"

In a landmark moment for its oncology ambitions, GSK has secured FDA approval<\/a> for Jideytro (zidesamtinib) as the first commercial lung cancer drug in the company\u2019s history.<\/p>\n

The milestone was made possible by GSK\u2019s recent acquisition of Nuvalent<\/a> for $10.6 billion. The approval for Jideytro comes just a week after the British pharma closed the deal<\/a> and about two months ahead of the FDA\u2019s target decision date of Sept. 18.\u00a0<\/p>\n

The green light allows Jideytro to treat adult patients with advanced ROS1-positive non-small cell lung cancer who received a prior ROS1 inhibitor.<\/p>\n

\u201cThe rapid progression of Jideytro from development to approval reflects both the strength of the underlying science and the urgent need for additional effective and tolerable treatments for ROS1-positive lung cancer,\u201d GSK\u2019s chief scientific officer, Tony Wood, said in a July 22 statement.<\/p>\n

By GSK\u2019s estimate, about 50,000 new cases of ROS1-positive NSCLC are diagnosed each year worldwide, mostly among non-smokers in their 40s and 50s who could stay on treatment for several years.<\/p>\n

GSK has suggested that Jideytro holds \u201cmulti-blockbuster potential,\u201d an ambitious projection considering none of the existing ROS1 NSCLC drugs\u2014by Pfizer, Roche, Bristol Myers Squibb and most recently, Nuvation Bio\u2014have come close to that target.\u00a0<\/p>\n

Jideytro differentiates itself from earlier therapies such as Pfizer\u2019s Xalkori and BMS\u2019 Augtyro through its unique molecular design. Nuvalent designed Jideytro to overcome treatment-emergent ROS1 mutations while sparing the structurally related TRK family, thereby preventing off-target toxicities. It features robust central nervous system penetration to tackle brain metastases, a common complication in ROS1-positive NSCLC.\u00a0<\/p>\n

In the single-arm Arros-1 phase 1\/2 clinical trial, Jideytro booked an objective response rate of 44% in 117 patients with ROS1 inhibitor-pretreated NSCLC. In terms of duration of response, 82% and 69% of responders remained in remission at six months and 12 months, respectively.\u00a0<\/p>\n

Among 50 patients who had measurable brain metastases, responses were observed in 48% of patients, including 22% with a complete response, according to the drug\u2019s label.<\/p>\n

A 50% ORR rate was also recorded in the 42 patients who had ROS1 resistance mutations.<\/p>\n

Despite the strong data, GSK has a long ways to go before Jideytro could reach blockbuster status. One of its primary competitors is Ibtrozi (taletrectinib)<\/a> by David Hung\u2019s Nuvation Bio. Following a line-agnostic FDA nod for ROS1-positive NSCLC in June 2025, Ibtrozi\u2014which also features intracranial activity and TRK sparing\u2014generated<\/a> $18.5 million during the first quarter of 2026.<\/p>\n

The current Jideytro label only allows the GSK drug to be used in patients who received a prior ROS1 inhibitor. Responding to a Fierce inquiry, a GSK spokesperson pointed to Nuvalent\u2019s previous comment that it would seek a first-line label expansion this year.\u00a0<\/p>\n

At the 2026 American Society of Clinical Oncology annual meeting, Nuvalent also reported promising preliminary data for zidesamtinib in non-NSCLC solid tumors, indicating the drug may hold pan-tumor potential with a 40% ORR across 10 tumor types.\u00a0<\/p>\n

Jideytro is the first product emerging from GSK\u2019s Nuvalent acquisition. Neladalkib, a fourth-generation ALK inhibitor, could be next with an FDA target action date of Nov. 27, 2026, for advanced ALK-positive NSCLC. GSK has floated multi-blockbuster hopes for that drug, too.<\/p>\n

Beyond the Nuvalent assets, GSK is advancing risvutatug rezetecan (ris-rez), a B7-H3-targeted antibody-drug conjugate, in a phase 3 extensive-stage small-cell lung cancer study. The drug\u2019s original developer, Hansoh Pharma, just reported<\/a> a phase 3 win in SCLC in China.\u00a0<\/p>\n","protected":false},"excerpt":{"rendered":"In a landmark moment for its oncology ambitions, GSK has secured FDA approval for Jideytro (zidesamtinib) as the…\n","protected":false},"author":2,"featured_media":94083,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_share_on_mastodon":"0"},"categories":[20784],"tags":[43120,20684,43121,29324,20785,28913,4198,28736,10253,29325],"class_list":["post-102744","post","type-post","status-publish","format-standard","has-post-thumbnail","category-gsk","tag-drug-approvals","tag-fda-approval","tag-fda-approvals","tag-fierce-pharma-homepage","tag-gsk","tag-lung-cancer","tag-marketing","tag-non-small-cell-lung-cancer","tag-pharma","tag-ros1"],"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@UnitedKingdom\/117088176226637571","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/posts\/102744","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/comments?post=102744"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/posts\/102744\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/media\/94083"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/media?parent=102744"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/categories?post=102744"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/tags?post=102744"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}