Zidesamtinib

GSK has announced the US Food and Drug Administration (FDA) has approved Jideytro (zidesamtinib), a ROS1 selective inhibitor, for the treatment of adult patients with locally advanced or metastatic ROS1-positive Non-Small Cell Lung Cancer (NSCLC) who received a prior ROS1 kinase inhibitor. The approval comes ahead of the original target action date of September 18, 2026 and follows the FDA's Breakthrough Therapy and Orphan Drug Designations. Jideytro, part of the portfolio from the recently completed acquisition of Nuvalent, Inc.3, was developed to address key efficacy and/or tolerability challenges of treating ROS1-postive NSCLC. Its next-generation design aims to combine high target-selectivity, broad coverage of ROS1 resistance mutations and blood-brain barrier penetration to address disease in the brain. Approximately, 50,000 people worldwide are diagnosed each year with ROS1-positive NSCLC, often non-smokers in their 40s and 50s who could stay on treatment for several years. Tony Wood, Chief Scientific Officer (CSO), GSK, said, "The 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. Today's approval provides an important new option for these patients and supports our strategy to acquire assets with validated targets that could meaningfully improve standards of care.” The approval of Jideytro is based on results from the global single-arm ARROS-1 phase 1/2 clinical trial in patients with advanced or metastatic ROS1-positive NSCLC previously treated with a ROS1 inhibitor. The study demonstrated meaningful and durable responses, including in patients with brain metastases and ROS1 resistance mutations. In the overall population (n=117), the Objective Response Rate (ORR) was 44 percent (95 percent Confidence Interval [CI]: 34-53 percent). Duration of response (DOR) rates at 6 and 12 months were 82 percent and 69 percent, respectively. The most common (≥15 percent) adverse reactions in the pooled safety population (n=446) included oedema, peripheral neuropathy, constipation, fatigue and dyspnoea. Alexander Drilon, MD, ARROS-1 trial investigator and Chief of the Early Development Service at Memorial Sloan Kettering Cancer Center, said, “Despite advances in treatment, resistance mutations, disease progression in the brain and treatment-related adverse events continue to create challenges for patients. The responses observed in ARROS-1, including in heavily pre-treated patients, represent meaningful progress for people living with this disease.” Jideytro is GSK's first approved medicine in lung cancer. The company is advancing additional medicines from the recent Nuvalent acquisition, including neladalkib (NVL-655) for patients with ALK-altered NSCLC, which is currently under FDA review with a target decision date of November 27, 2026, and NVL-330, an investigational treatment for HER2-altered NSCLC. Janet Freeman-Daily, Co-Founder and President, The ROS1ders, said, "For patients, the goal is not just more time, but quality time to live life as normally as possible while on treatment. The ROS1-positive community is deeply invested in advancing care with treatments that are effective and tolerable. Today's approval gives patients and their doctors an important new option and represents meaningful progress for our community." GSK is also advancing risvutatug rezetecan (Ris-Rez), a B7-H3-targeted Antibody Drug Conjugate (ADC) in late-stage development with recently reported positive phase 3 data in relapsed Small-Cell Lung Cancer (SCLC) from licensor Hansoh Pharma Inc.

iStock, beast01 Jideytro is GSK’s first approved product for lung cancer. With its takeover of Nuvalent Bio last month and a deal with Hansoh Pharmaceutical in 2023, the pharma now has several other lung cancer assets in late-stage development. The FDA has signed off on GSK’s ROS1 inhibitor zidesamtinib, one of the main bounties from its recent multibillion buy of Nuvalent Bio, for certain types of lung cancer. The drug will carry the brand name Jideytro. Jideytro is indicated for patients with advanced non-small cell lung cancer (NSCLC) who are positive for the ROS1 gene fusion —a particular mutation that triggers uncontrolled cell growth—and who have undergone a prior line of ROS1-directed therapy. The regulatory win represents GSK’s market entry into lung cancer, according to a Wednesday announcement . The approval also delivers a quick return on GSK’s $10.6 billion acquisition of Nuvalent Bio, which was announced in June and closed last week . The buyout is among the industry’s largest of the year so far. In addition to zidesamtinib, the acquisition gave GSK the ALK blocker neladalkib. That asset is currently under FDA review for NSCLC, with an approval decision expected by Nov. 27 . ezstandalone.cmd.push(function () { ezstandalone.showAds(129); }); Jideytro—and neladalkib, if approved—both have “multi-blockbuster potential,” GSK said in its news release announcing the Nuvalent deal back in June. Around 50,000 people globally are diagnosed with ROS1-positive NSCLC every year, the pharma added on Wednesday, many of whom are non-smokers in middle-age “who could stay on treatment for several years.” Mergers & acquisitions GSK pays $10.6B for cancer biotech Nuvalent in industry’s second-biggest buy of the year Nuvalent Bio is GSK’s third big-ticket purchase this year, after the pharma dropped $2.2 billion in January for RAPT Therapeutics and $950 million in February for 35Pharma. June 9, 2026 · 2 min read · Tristan Manalac Read more Data from the Phase 1/2 single-arm ARROS-1 clinical trial supported Jideytro’s approval, demonstrating an overall response rate of 44%. Duration of response rate was 82% at six months and 69% at 12 months. The drug showed “meaningful and durable responses” even in Patients with brain metastases and ROS1 resistance mutations, according to GSK. Aside from Jideytro and neladalkib, GSK gained a third NSCLC drug candidate from Nuvalent dubbed NVL-330. The asset is in early-stage development for HER2-altered NSCLC, with enrollment currently ongoing for a Phase 1a/1b study, according to a federal trials database . The Nuvalent-acquired assets join GSK’s Hansoh Pharmaceutical–partnered antibody-drug conjugate (ADC) risvutatug rezetecan (ris-rez), which the collaborators are also advancing for NSCLC. Data from the Phase 3 ARTEMIS-008 trial earlier this month showed significantly better overall survival outcomes in patients on ris-rez versus standard of care. These findings have emboldened Hansoh to seek approval for ris-rez in China. GSK paid $185 million upfront in December 2023 for the license to develop and commercialize ris-rez outside of mainland China, Taiwan, Hong Kong and Macau. Up to $1.525 billion is on the line in milestones. Antibody-drug conjugates GSK and Hansoh’s ADC clinches late-stage win, teeing up regulatory submission in China GSK and Hansoh Pharmaceutical’s antibody-drug conjugate success validates their partnership, one of the many deals in which Big Pharma has tapped a China company for promising cancer candidates. July 10, 2026 · 1 min read · Gabrielle Masson Read more