Latest news with #OncomineDx
Medscape
a day ago
- Health
- Medscape
Sunvozertinib Wins Approval for EGFR-Mutated NSCLC
The FDA has granted accelerated approval to sunvozertinib (Zegfrovy, Dizal Pharmaceutical) for locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor ( EGFR) exon 20 insertion mutations that's progressed on or after platinum-based chemotherapy. The agency also approved Oncomine Dx Express Test (Life Technologies Corporation) as a companion diagnostic to detect the mutations. The oral EGFR inhibitor is the first small molecule approved in the US for the indication; it was previously approved in China. The intravenous bispecific antibody amivantamab-vmjw (Rybrevant, Johnson & Johnson) also carries a second-line indication for EGFR exon 20 insertion mutated advanced/metastatic NSCLC, as well as a first-line indication with carboplatin and pemetrexed. Dizal is going for a first-line indication, too. The company recently announced completion of enrolment in a phase 3 trial pitting sunvozertinib against platinum-based chemotherapy for the upfront treatment of EGFR exon 20 insertion mutated NSCLC. The new second-line approval was based on WU-KONG1B, a multinational dose finding trial. All subjects had previous platinum-based chemotherapy and 43.4% had also received immunotherapy; 13.3% had been on amivantamab. Among 85 patients on 200 mg sunvozertinib daily, the overall response rate was 46% and the duration of response was 11.1 months. Labelling warns of the possibility of interstitial lung disease/pneumonitis, gastrointestinal adverse reactions, dermatologic issues, ocular toxicity, and embryo-fetal toxicity. Diarrhea, skin rash, and creatine phosphokinase increase were the most common drug-related treatment emergent adverse events in the trial, with most events being grade 1 or 2. The recommended dose is 200 mg orally once daily with food until disease progression or unacceptable toxicity. M. Alexander Otto is a physician assistant with a master's degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who worked for several major news outlets before joining Medscape. Alex is also an MIT Knight Science Journalism fellow. Email: aotto@
Yahoo
a day ago
- Business
- Yahoo
Thermo Fisher's NGS Assay Receives FDA Approval as a Companion Diagnostic for ZEGFROVY and for Tumor Profiling
Oncomine Dx Express Test on the Ion Torrent Genexus Dx Integrated Sequencer generates results in as little as 24 hours to support timely therapy decisions CARLSBAD, Calif., July 03, 2025--(BUSINESS WIRE)--Thermo Fisher Scientific, the world leader in serving science, today announced the U.S. Food and Drug Administration (FDA) has approved the Oncomine™ Dx Express Test on the Ion Torrent™ Genexus™ Dx Integrated Sequencer as an in vitro diagnostic (IVD) assay for use as a companion diagnostic (CDx) for Dizal's ZEGFROVY® (sunvozertinib) and in tumor profiling. This approval brings rapid next-generation sequencing (NGS) to decentralized clinical settings closer to where patients receive care. With the ability to deliver essential genomic insights in as little as 24 hours*, this approval helps advance the accessibility of precision oncology tools and enables more timely decision making. A patient's tumor profile has the potential to guide precision oncology care. However, delays in obtaining results can hinder clinicians' ability to make informed decisions, potentially causing patients to miss out on targeted therapies, which can impact treatment efficacy and patient outcomes. Furthermore, a significant number of patients miss out on targeted therapies due to inefficiencies or lack of access to testing, highlighting the critical role of timely genomic profiling. The Oncomine Dx Express Test was designed to simplify the NGS workflow and connect patients everywhere to precision oncology. Now with the Oncomine Dx Express Test on the Ion Torrent Genexus Dx Integrated Sequencer, laboratories across a variety of clinical settings can deliver rapid genomic profiling with exceptional accuracy and ease, helping to ensure patients can benefit from the latest advancements in precision oncology. The Oncomine Dx Express Test is intended for use as a companion diagnostic for ZEGFROVY (sunvozertinib), a targeted therapy from Dizal, to identify patients with non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations. In addition, the test has been approved for tumor profiling in solid tumors and detects cancer mutations with evidence of clinical significance and potential clinical significance across 46 genes. Accelerating informed precision oncology care The Genexus Dx Integrated Sequencer automates the NGS workflow — from sample preparation to data analysis and reporting — making the technology accessible to more laboratories, including those that are smaller and without previous NGS expertise. It also enables laboratories to generate timely CDx results as well as tumor profiling reports in as little as 24 hours, helping accelerate insights and access to precision oncology. "NGS has been instrumental in advancing precision oncology, but these insights often aren't available early enough to inform real-world care," said Kathy Davy, president of Clinical Next-Generation Sequencing at Thermo Fisher Scientific. "With our rapid NGS solutions, we aim to deliver timely results to clinicians and their patients prior to the initiation of treatment. We've been leading companion diagnostics in collaboration with our pharma partners for a decade, and this approval signifies the next step in our journey bringing rapid, decentralized NGS CDx to drug development. We are proud of our collaboration with Dizal to bring ZEGFROVY to the US market." Biodesix, one of Thermo Fisher's collaborators in the validation of Oncomine Dx Express Test on the Genexus Dx Integrated Sequencer, will be the first lab to launch testing services. "The Biodesix team is excited at the prospect of using the newly FDA approved Genexus Dx Integrated Sequencer for clinical testing using the Oncomine Dx Express test and for supporting our biopharma client projects," said Gary Pestano, Ph.D., chief development officer at Biodesix. "Automation of the systems for nucleic acid purification, library preparation, sequencing and report generation has the potential to significantly improve our NGS laboratory workflows by reducing hands-on time and by delivering rapid turnaround times - from sample receipt to results." ZEGFROVY (sunvozertinib) CDx approval ZEGFROVY, developed by Dizal, was granted FDA accelerated approval following Breakthrough Therapy designation and Priority Review for the treatment of NSCLC patients with EGFR exon 20 insertion mutations. With the approval of the Oncomine Dx Express Test on the Genexus Dx Integrated Sequencer as a companion diagnostic for this therapy, clinicians can now quickly identify eligible patients – supporting earlier intervention and expanding access to targeted therapy. "ZEGFROVY is a highly effective and currently the only approved EGFR TKI targeting EGFR exon 20 insertion mutations. The approval of ZEGFROVY will have a significant impact on platinum-pretreated patients with NSCLC harboring EGFR exon 20 insertion mutations, a difficult-to-treat lung cancer subtype," said Susan Chen, senior vice president, head of clinical operation at Dizal. "Today's FDA approval of the Oncomine Dx Express Test offers access to ZEGFROVY through decentralized companion diagnostic testing. The ability to match patients to our therapy quickly and accurately, regardless of mutation location, can improve outcomes for this patient population." To learn more about today's approval, please visit * Timing varies by number of samples and type of run. About Thermo Fisher ScientificThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue over $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit View source version on Contacts Media Contact Information:Jen CarrollPhone: (760) 583-8898Email: Jessika ParryPhone: (419) 266-4016Email: jparry@
