Sunvozertinib Wins Approval for EGFR-Mutated NSCLC
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@mdedge.com
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Fox News
26 minutes ago
- Fox News
First lady Melania Trump makes 'heartwarming' visit to kids at hospital for 'Be Best' event
Ahead of Independence Day this year, first lady Melania Trump visited Children's National Hospital (CNH) in Washington, D.C., on Thursday afternoon in her latest "Be Best" event. The first lady joined patients battling cancer, kidney and heart issues, among other diagnoses, in the garden room to participate in various patriotic arts and crafts, including rock painting. Nicholas Clemens, communications director at the Office of the First Lady, told Fox News Digital, "Mrs. Trump and our team really cherished being with these brave kids and their caregivers." The first lady greeted inpatient and outpatient children with gifts such as teddy bears, puzzles, books and "Be Best" temporary tattoos. "It was fun to see them light up when they talked with Mrs. Trump about their favorite sports and music, and especially when they saw the BE BEST teddy bears," added Clemens. "It was a great reminder of why Mrs. Trump is working so hard to advocate for the well-being of children and youth through BE BEST. We really thank Children's National for a memorable and heartwarming visit," said Clemens. Mrs. Trump helped unveil "Eternal Flame," a hybrid Tea Rose sourced from the White House gardens. Hybrid tea roses have high centers, long stems with high-centered blooms and a strong floral fragrance perfect for a cutting garden, according to the Missouri Botanical Garden. Accompanying Mrs. Trump was Dale Haney, White House Grounds superintendent. He discussed the new rose bush with the first lady and with CNH President and CEO Michelle Riley-Brown, along with the kids. Both inpatient children and outpatient children joined the first lady in the Bunny Mellon Healing Garden to place rocks, pinwheels and American flags among the plants and flowers. Following the day of festivities, the first lady visited a three-month-old in the heart and kidney unit, sharing a very special moment. The child has had five different surgeries performed since his birth. Mrs. Trump met the child along with his military family, sharing many hugs. While in the heart and kidney unit, the first lady also met with a teenage boy admitted recently and his family. Mrs. Trump previously visited the Children's National Hospital in 2017 to dedicate the Bunny Mellon Healing Garden. The garden is dedicated to the First Ladies of the United States after philanthropist and horticulturalist Rachel "Bunny" Lambert Mellon and is situated on a rooftop spanning 7,200-square-feet.
CBS News
40 minutes ago
- CBS News
Jackson South to close maternity unit this fall as part of systemwide realignment
Jackson Health System announced Thursday it will close the maternity unit at Jackson South Medical Center this fall, citing a shift in community needs and a broader strategy to support the hospital's ongoing growth. The move comes more than two decades after Jackson South opened in 2001 and nearly a decade after it expanded emergency services with the addition of Ryder Trauma at Jackson South in 2016, the health system said. "Closure will help better align services" In a statement, a spokesperson for the health system said the closure will help better align services with the current demands of the surrounding community in southern Miami-Dade County and the Florida Keys. "Jackson South's continued success relies on adapting to our patients' needs," the statement said. "While the types of services offered may vary from hospital to hospital, as a system, we provide the most comprehensive, high-quality care for every patient." Employees affected Hospital officials said employees affected by the maternity unit closure will be offered opportunities at other Jackson South departments or similar units across the Jackson Health System. What about the moms-to-be? Expectant mothers nearing their delivery dates will continue to receive care at Jackson South. Others earlier in their pregnancies will be transitioned to other centers. Comprehensive maternity services — including high-risk obstetric care — will remain available at The Women's Hospital at Jackson Memorial and Jackson North Medical Center, the health system said. The Women's Hospital at Jackson Memorial and Jackson North Medical Center is at least 20 miles further. "We're just really sad to hear that they're going to shut down the delivery unit," expecting mom Bianka Ramirez said. Ramirez is due on July 30th. During her checkup Thursday, she found out she'll be among the last to have her baby at Jackson South. "She told us that, unfortunately, by September, they're going to shut it down and if we are planning to have kids in the future, we might not be able to come to this hospital." Jackson South will continue operating its OB-GYN physician practice in collaboration with UHealth – University of Miami Health System. Jackson also pledged to maintain prenatal care access for underserved populations through its ongoing partnership with Community Health of South Florida (CHI). Sheila Simms Watson, a licensed midwife with the Southern Birth Justice Network, said, "What's the community going to do? Where are we going to go?" Simms Watson said this will only hurt the already underserved area, with a lack of other options that aren't private and may not accept everyone's insurance. She says more expecting moms may consider birthing centers or even delivering at home. "So, it's a delay in care and that delay in care can be the difference between life and death, to put it bluntly." Both women now hope the hospital will reconsider. "Rethink about all the great doctors you have there and all the people that want to have kids there," Ramirez said. CBS News Miami requested an interview with hospital leadership but was told no. The maternity ward here is set to close in the fall; no word on an exact date yet.
Yahoo
an hour ago
- Yahoo
Housing First intervention associated with reduced opioid overdoses
Opioid use disorder (OUD) has become a mounting public health crisis in the US, often disproportionately affecting individuals in the most vulnerable socioeconomic statuses. The homeless population has recently shown particularly high rates of OUD and opioid addiction, which has provoked debates over the most effective strategies for treating substance abuse while humanely and equitably promoting public safety in afflicted areas. Among the most controversial approaches is the Housing First philosophy, which posits that providing free or low-cost living accommodations for people experiencing homelessness facilitates addiction treatment, especially if accompanied by pharmacotherapy and mental health counselling. In the June 2025 edition of JAMA Network Open, Isabelle Rao and Margaret Brandeau simulated the effects of Housing First interventions on OUD overdoses and mortality under various conditions. The study concludes that a Housing First approach to OUD patients experiencing homelessness, whether accompanied by treatment or not, leads to a reduction in both overdoses and mortality. GlobalData epidemiologists forecast growth in the 12-month diagnosed prevalent cases of opioid addiction with OUD from over 739,000 to approximately 773,000 between 2025 and 2033. Successful implementation of interventions such as Housing First may reduce severe injury or death in this growing patient pool, particularly among those experiencing housing instability or homelessness. Rao and Brandeau modelled various scenarios in which a nationally representative patient population of 1,000 adults with OUD experiencing homelessness were either provided with free or affordable housing or none over five years. Additionally, these populations were simulated to receive methadone therapy under both housing conditions. As displayed in Figure 1, total overdoses over five years were notably lower among individuals provided with housing, at 464 per 1,000 population in those exposed to the Housing First intervention and 533 in the unexposed group over five years. This pattern was found among both fatal and nonfatal overdoses. Similarly, all-cause mortality simulation showed 132 deaths per 1,000 population among housed OUD patients compared to 186 among those without housing (Figure 2). The authors attribute the lower mortality rate to the significant reduction in fatal overdoses in the housed population. In addition to the improvements in health outcomes for OUD patients provided with housing, the cost-effectiveness analysis suggests that a Housing First policy would be more effective when compared to the status quo due to direct and indirect cost benefits from curbing homelessness and OUD overdoses. The work by Rao and Brandeau offers a valuable contribution to the ongoing polemical debates over homelessness and opioid addiction in the US. As officials seek solutions for the treatment and rehabilitation of individuals suffering from these social and medical conditions, data such as that of the authors is critical in order to guide or refine policy solutions. However, Housing First should be only one component of a wider suite of actions to curb opioid addiction, including education of healthcare providers and patients, enforcement of limitations on irresponsible prescribing habits among physicians, and increasing the availability of life-saving treatments such as naloxone. In the absence of such comprehensive, concerted effort, the opioid crisis will continue to have a sizable impact on countless American communities. "Housing First intervention associated with reduced opioid overdoses" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
