The brain-penetrant, TRK-sparing, ROS1-selective TKI zidesamtinib was active and safe in patients with advanced ROS1+ non–small cell lung cancer.

Zidesamtinib is indicated for patients who received a prior ROS1 inhibitor

Zidesamtinib, a selective ROS1 inhibitor, was well tolerated and showed antitumor activity in pretreated, advanced ROS1-positive NSCLC.

Joshua K. Sabari, MD, discusses the design of the phase 1/2 ARROS-1 study, as well as key efficacy data with zidesamtinib in ROS1 fusion–positive NSCLC.

The good news The U.S. Food and Drug Administration (FDA) approved zidesamtinib for adults with locally advanced or metastatic ROS1-positive (+) non-small cell lung cancer (NSCLC) who received a…

Nuvalent, Inc. will showcase vital data regarding its cancer therapies, neladalkib and zidesamtinib, at the upcoming ASCO 2026 conference, promising significant breakthroughs.

Deal includes two late-stage molecules to augment GSK's renewed cancer therapy pipeline

GSK to acquire Nuvalent for $10.6B, gaining two lung cancer drugs — zidesamtinib and neladalkib — both under FDA review in 2026.

Nuvalent, a clinical-stage biopharmaceutical company, will present innovative preclinical findings for its cancer therapies at the AACR Annual Meeting 2025 in Chicago.

GSKは2026年7月22日、ROS1選択的阻害薬「Jideytro」（zidesamtinib）が既治療のROS1陽性非小細胞肺がんを対象に米FDAの承認を取得したと発表した。ARROS-1試験の主要結果と安全性、臨床的含意を整理する。

Strategy prioritizes most accelerated path to first potential approval  Initial NDA submission expected by mid-year for zidesamtinib in TKI pre-treated ROS1-positive NSCLC population, with topline piv...

Nuvalent (Nasdaq: NUVL) announced FDA acceptance and Priority Review of its New Drug Application for neladalkib, an investigational ALK-selective inhibitor for TKI pre-treated advanced ALK-positive NSCLC, with a PDUFA target action date of November 27, 2026.The NDA is supported by ALKOVE-1 Phase 1/2 data, with additional data to be presented at ASCO 2026. Nuvalent also highlighted that NDAs for both neladalkib and zidesamtinib in TKI pre-treated populations are under FDA review, and appointed Georg Pirmin Meyer, M.D. as Chief International Officer to lead international expansion.

Early efficacy among the highest seen in lung cancer, expert says

Des chercheurs annoncent 94 % de réponses contre certains cancers du poumon : peut-on déjà parler de percée ?Des chercheurs ont récemment présenté des résultats prometteurs concernant un nouveau traitement, le zidesamtinib, ciblant les anomalies génétiques liées au gène ROS1, qui affectent environ 2

A new drug called zidesamtinib shrank tumors in 93% of patients with ROS1-positive lung cancer. The results come from a global trial and offer hope for advanced cases.

Early efficacy among the highest seen in lung cancer, expert says

The recent Phase I/II ARROS-1 trial results highlight zidesamtinib's significant effectiveness in ROS1-positive NSCLC patients, showcasing high response rates and strong intracranial activity.

A new drug called zidesamtinib shrank tumors in 93% of patients with ROS1-positive lung cancer. The results come from a global trial and offer hope for advanced cases.

New results from the global phase 1/2 ARROS-1 trial showed clinically meaningful activity with zidesamtinib in patients with advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who had not previously received a tyrosine kinase inhibitor (TKI). The findings were presented at the International Association for the Study of Lung Cancer (IASLC) 2026 World Conference on Lung Cancer (WCLC).