Latest news with #Emrelis
Yahoo
23-05-2025
- Business
- Yahoo
NeoGenomics introduces c-MET companion diagnostic for NSCLC
NeoGenomics has commercially launched the c-MET Companion Diagnostic (CDx) for use in non-small cell lung cancer (NSCLC), offering a 48-hour turnaround for oncologists and pathologists. This new immunohistochemistry (IHC) assay is designed to detect the overexpression of c-Met (mesenchymal-epithelial transition factor) protein, which is found in up to half of individuals with advanced NSCLC. The c-MET CDx for NSCLC assay is intended to detect individuals who may benefit from targeted therapies such as AbbVie's Emrelis (telisotuzumab vedotin-tllv), which was recently approved by the US Food and Drug Administration (FDA). Developed in line with the regulator's guidance, the assay is said to be validated for use with MET-targeted treatments while enabling timely clinical decision-making. NeoGenomics noted that the assay complements the company's PanTracer portfolio, which includes genomic and immuno-oncology markers. It forms part of the company's extensive NSCLC testing offerings, supporting the adoption of MET-directed treatments and the advancement of precision cancer care. Headquartered in the US, NeoGenomics focuses on cancer genetics testing and information services and provides a range of oncology-focused tests. NeoGenomics medical services vice-president Dr Nathan Montgomery said: 'Accurate and timely biomarker testing is critical in lung cancer, where targeted therapies can meaningfully change the course of a patient's treatment. 'The c-MET CDx for NSCLC assay adds an important tool to our testing portfolio, helping oncologists quickly identify patients who may benefit from MET-directed therapies. It also complements our PanTracer suite, enabling comprehensive biomarker profiling for NSCLC.' In October 2024, the company announced the receipt of conditional approval from the New York State Department of Health for two next-generation sequencing (NGS) tests, the Neo Comprehensive Solid Tumor assay and the NeoTYPE DNA & RNA Lung. "NeoGenomics introduces c-MET companion diagnostic for NSCLC" was originally created and published by Medical Device Network, 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. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
WebMD
16-05-2025
- Health
- WebMD
FDA OKs New Treatment for Hard-to-Treat Lung Cancer
May 16, 2025 – The FDA has granted fast-track approval to a first-of-its-kind treatment for a type of advanced lung cancer. The treatment, which is known as telisotuzumab vedotin but sold as Emrelis, is for adults with non-squamous non-small-cell lung cancer (NSCLC) that makes too much of a protein called c-Met and who have received prior therapy. By targeting NSCLC tumors that overproduce c-Met, Emrelis offers a more personalized treatment option based on patients' unique cancer markers, particularly for those who no longer respond to standard therapy. The FDA has also approved a lab test made by Roche Diagnostics to detect high levels of c-Met protein to see if a patient may benefit from Emrelis. Lung cancer is the leading cause of cancer-related deaths, with NSCLC accounting for about 85% of cases. About 25% of people with advanced NSCLC overproduce c-Met, which makes the cancer more aggressive and harder to treat. Emrelis was approved based on a clinical trial that tested how well it worked in 84 previously treated patients with NSCLC whose tumors overproduced c-Met. Results showed that 35% of patients responded to the new treatment, which lasted 7.2 months, on average Continued approval for this use will depend on confirmation of the treatment's benefits in future clinical trials, according to AbbVie, the maker of Emrelis. A global trial is also under way to test Emrelis alone for the same condition. Emrelis is part of a class of medicines called antibody-drug conjugates (ADCs), which are designed to target cancer cells while leaving healthy cells alone. It combines a monoclonal antibody called telisotuzumab, which homes in on a protein called c-Met, with a cancer-fighting drug called monomethyl auristatin E (MMAE). Emrelis attaches to cancer cells that produce too much c-Met and delivers MMAE directly inside them, where it blocks cell division and stops the cancer from growing. The medicine will be given as IV infusion every two weeks, for as long as the treatment works and the side effects are tolerable. "People with c-Met overexpressing NSCLC have poor prognosis and limited treatment options, and Emrelis is a first-in-class ADC that can address a critical unmet need for this patient population," Jonathan Goldman, MD, a professor of medicine and director of thoracic oncology clinical trials at the University of California, Los Angeles, said in a statement. The most common side effects of Emrelis include nerve problems in the hands and feet, fatigue, loss of appetite, swelling in the arms or legs, infusion-related reactions, and changes in blood test results, such as elevated liver enzymes or low levels of hemoglobin, sodium, phosphorus, calcium, and white blood cells. Before starting Emrelis, patients should tell their doctor about their medical history, especially if they have nerve issues, lung or breathing problems (other than lung cancer), eye problems, or liver disease. Emrelis can harm an unborn baby, so women who are pregnant or planning to become pregnant should tell their doctor. Women who can become pregnant should take a pregnancy test before starting treatment and use birth control during treatment and for two months after the last dose. Men with partners who can become pregnant should also use birth control during treatment and for four months afterward. Patients should not breastfeed while taking Emrelis and for a month after the final dose, as it's unknown whether the drug passes into breast milk. It's also important to tell the doctor about any medications, supplements, or vitamins being taken, as some may increase the risk of side effects when combined with Emrelis. Patients should contact their doctor right away if they have numbness, muscle weakness, a hard time walking, trouble breathing, wheezing, chest discomfort, fever or chills, blurred vision, eye pain or swelling, itching, a rash, or headaches.
Forbes
16-05-2025
- Business
- Forbes
Is It Time To Buy AbbVie Stock At $180?
CANADA - 2025/04/03: In this photo illustration, the AbbVie logo is seen displayed on a smartphone ... More screen. (Photo Illustration by Thomas Fuller/SOPA Images/LightRocket via Getty Images) AbbVie (NYSE:ABBV) stock has garnered recent attention following the FDA approval of Emrelis for adults with previously treated lung cancer who exhibit an overabundance of the c-Met protein. This protein is known to promote tumor growth and resistance to certain therapies. This positive news coincides with ABBV's strong stock performance, which has risen nearly 10% in the past six months, notably outperforming the broader S&P Healthcare index, which has declined by 8%. Contributing significantly to AbbVie's positive trajectory is the exceptional growth within its immunology portfolio, particularly Skyrizi and Rinvoq. These two drugs demonstrated substantial year-over-year growth of 71% and 57%, respectively, in the first quarter of 2025, building upon their impressive 50% growth in the previous year. While the stock's current high valuation introduces a degree of risk, we maintain a positive outlook on AbbVie. This conclusion is based on a comparative analysis of the company's present valuation against its recent operating performance, as well as its current and historical financial condition. Our assessment across key parameters—Growth, Profitability, Financial Stability, and Downturn Resilience—indicates that AbbVie possesses a strong operating performance and a sound financial condition, as detailed below. Despite concerns surrounding potential drug price controls, which Wall Street analysts anticipate will likely face legal challenges and be difficult to implement, AbbVie's specific performance appears robust, largely driven by its successful immunology drugs. However, for investors who seek lower volatility than individual stocks, the Trefis High Quality portfolio presents an alternative - having outperformed the S&P 500 and generated returns exceeding 91% since its inception. Separately, see – Is UNH Stock Now A Falling Knife? Going by what you pay per dollar of sales or profit, ABBV stock looks expensive compared to the broader market. AbbVie's Revenues have grown marginally over recent years. AbbVie's profit margins are around the median level for companies in the Trefis coverage universe. AbbVie's balance sheet looks weak. ABBV stock has been much more resilient than the benchmark S&P 500 index during some of the recent downturns. While investors have their fingers crossed for a soft landing by the U.S. economy, how bad can things get if there is another recession? Our dashboard How Low Can Stocks Go During A Market Crash captures how key stocks fared during and after the last six market crashes. In summary, AbbVie's performance across the parameters detailed above are as follows: In addition: See Buy or Sell AbbVie Stock. AbbVie's performance, when initially compared to the benchmark S&P 500 index across the aforementioned parameters, appears moderate. However, a closer examination of the adjusted figures reveals a more compelling picture. For example, the company boasts a robust adjusted net income margin of 32%. Furthermore, its price-to-earnings (P/E) ratio, based on adjusted trailing earnings of $10.27 per share, stands at a reasonable 18x. While this 18x multiple is higher than the stock's three-year average P/E ratio of 14x, we believe this premium is warranted due to the exceptional growth within AbbVie's immunology portfolio. Consequently, we view ABBV stock as a favorable investment at its current levels. Adding to this positive outlook, the average analyst price target of $211 suggests a potential upside of over 15% from the current price. While ABBV stock looks promising, investing in a single stock can be risky. On the other hand, the Trefis High Quality (HQ) Portfolio, with a collection of 30 stocks, has a track record of comfortably outperforming the S&P 500 over the last 4-year period. Why is that? As a group, HQ Portfolio stocks provided better returns with less risk versus the benchmark index; less of a roller-coaster ride as evident in HQ Portfolio performance metrics.
Medscape
15-05-2025
- Health
- Medscape
Telisotuzumab Vedotin Approved for NSCLC
The US Food and Drug Administration (FDA) has granted accelerated approval to telisotuzumab vedotin-tllv (Emrelis, AbbVie) for locally advanced or metastatic nonsquamous non–small cell lung cancer (NSCLC) with high c-Met protein overexpression after prior systemic therapy. The FDA also approved the VENTANA MET (SP44) RxDx Assay (Roche Diagnostics) as a companion diagnostic to detect high c-Met protein overexpression, defined as 50% or more of tumor cells with 3+ staining. The antibody-drug conjugate consists of a c-Met–directed antibody and microtubule inhibitor conjugate. Telisotuzumab vedotin-tllv 'is the first and only treatment approved for previously treated advanced NSCLC patients with high c-Met protein overexpression who often face poor prognosis and have limited treatment options,' AbbVie said in a press release. C-Met is a cell surface protein that is overexpressed in approximately 25% of patients with advanced epidermal growth factor receptor (EGFR) wild-type, nonsquamous NSCLC, driving tumor progression. Roughly half of overexpressors have high c-Met expression. Approval was based on the phase 2 LUMINOSITY trial in 84 patients with EGFR wild-type, nonsquamous NSCLC and high c-Met protein overexpression. Patients received telisotuzumab vedotin-tllv as monotherapy in the second or third-line setting. The overall response rate was 35%, and the median duration of response was 7.2 months. The most common adverse reactions, in 20% or more of study participants, were peripheral neuropathy, fatigue, decreased appetite, and peripheral edema. The most common grade 3 or 4 laboratory abnormalities, in 2% of more of participants, were decreased lymphocytes, increased glucose, increased alanine aminotransferase, increased gamma glutamyl transferase, decreased phosphorus, decreased sodium, decreased hemoglobin, and decreased calcium. The recommended telisotuzumab vedotin-tllv dose is 1.9 mg/kg intravenously up to a maximum of 190 mg for patients who weigh 100 kg or more every 2 weeks until disease progression or unacceptable toxicity. The treatment is being further evaluated in the phase 3 trial TeliMET, AbbVie noted in the press release.
Yahoo
14-05-2025
- Health
- Yahoo
US FDA approves AbbVie's drug for a type of lung cancer
(Reuters) -The U.S. Food and Drug Administration has approved AbbVie's drug to treat adults with a type of lung cancer who have received previous treatment, the drugmaker said on Wednesday. The treatment, branded as Emrelis, belongs to a class of drugs known as antibody-drug conjugates, which act as "guided-missiles" that target only cancer cells while sparing healthy cells, unlike conventional chemotherapy. Emrelis was approved for a type of non-squamous non-small cell lung cancer (NSCLC), for which patients were previously treated with other drugs but the disease still spread to other parts of the body. These patients also showed an excess of c-Met protein, which is known to trigger tumor development and resistance to certain therapies. According to the National Institutes of Health, about 25%-37% of patients with this type of lung cancer exhibit high c-Met protein overexpression. NSCLC is the most common type of lung cancer in the United States, accounting for roughly 197,000 new NSCLC cases in a year, according to the American Cancer Society. The FDA's accelerated approval of Emrelis was based on a mid-stage trial of 84 patients, where the drug showed an overall response rate of 35%. It is currently being evaluated in a late-stage trial. Other treatment options for NSCLC include Merck's blockbuster Keytruda and AstraZeneca's Tagrisso, which belong to different classes of drugs.
