Latest news with #HER2positive
Yahoo
07-07-2025
- Business
- Yahoo
Jazz Pharmaceuticals' Ziihera Receives Conditional European Approval for Advanced Biliary Tract Cancer
Jazz Pharmaceuticals (NASDAQ:JAZZ) is one of the best high short interest stocks with huge upside potential. On July 2, Jazz Pharmaceuticals announced that the European Commission/EC had granted conditional marketing authorization for its new bispecific antibody, called Ziihera (zanidatamab), for the treatment of biliary tract cancer/BTC. The approval extends to all European Union member states, as well as Norway, Iceland, and Liechtenstein. Ziihera is authorized as a single agent for adults with unresectable locally advanced or metastatic HER2-positive (IHC 3+) BTC who have previously received at least one line of systemic therapy. The recommended dose for zanidatamab is 20mg/kg, administered intravenously every two weeks, until disease progression or unacceptable toxicity. A biopharmaceutical scientist in their lab, studying a newly-diagnosed therapy-related acute myeloid leukemia. . The EC's decision was supported by data from the Phase IIb HERIZON-BTC-01 trial, which included 87 participants with previously treated, locally advanced or metastatic HER2-positive BTC. The continuation of this conditional approval depends on further clinical benefits being demonstrated in the ongoing Phase III HERIZON-BTC-302 trial. Jazz Pharmaceuticals (NASDAQ:JAZZ) identifies, develops, and commercializes pharmaceutical products in the US, Europe, and internationally. While we acknowledge the potential of JAZZ as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the . READ NEXT: and . Disclosure: None. This article is originally published at Insider Monkey.
Medscape
24-06-2025
- Health
- Medscape
Metastatic Breast Cancer Highlights From ASCO 2025
An exceptional range of practice-changing advancements in metastatic breast cancer across all subtypes were presented at ASCO 2025 and are discussed by Dr Ann Partridge of the Dana-Farber Cancer Institute. Beginning with HER2-positive disease, Dr Partridge reports on the DESTINY-Breast09 trial investigating whether trastuzumab deruxtecan (T-DXd) + pertuzumab (P) could improve upon results from the standard of care regimen, taxane + trastuzumab + P (THP), in the first-line setting. T-DXd + P increased progression-free survival (PFS), offering a future option for patients with very aggressive disease — although, Dr Partridge notes, several clinical questions remain. She highlights three studies in HER2-negative disease, starting with the SERENA-6 trial in which some patients treated with endocrine therapy who had ESR1 mutation, detected by circulating tumor DNA analysis, were switched to camizestrant. The camizestrant arm demonstrated meaningful PFS improvement. She also notes the first phase 3 trial of a proteolysis-targeting chimera, vepdegestrant, which demonstrated improved PFS in patients with ESR1 mutation. Continuing in the HER2-negative setting, she reports the updated overall survival results for inavolisib that continue to demonstrate positive PFS results. Switching gears to triple-negative disease, she discusses promising results from the ASCENT-04 trial, which tested the antibody-drug conjugate sacituzumab govitecan against chemotherapy.
Medscape
24-06-2025
- Health
- Medscape
Integrating ASCO 2025 Insights in Early-Stage Breast Cancer
Mariana Chavez MacGregor, MD, reflects on the 2025 ASCO Annual Meeting and its immediate impact on her clinical practice, particularly for patients with early-stage breast cancer. She describes applying findings from the neoCARHP study to personalize treatment for a patient with HER2-positive disease by safely omitting carboplatin to reduce toxicity. She also emphasizes the importance of addressing sexuality in cancer survivorship, empowered by educational sessions that offered practical ways to initiate these sensitive conversations. Finally, Dr Chavez MacGregor highlights a plenary session on structured exercise improving survival in colorectal cancer survivors, reinforcing how lifestyle interventions can enhance both quality of life and outcomes across oncology care.
Medscape
24-06-2025
- Health
- Medscape
Early Breast Cancer Highlights From ASCO 2025
Reporting on studies in early breast cancer presented at ASCO 2025, Dr Ian Krop of Yale Cancer Center discusses potential refinements in treatment across all subtypes as well as a significant study in supportive care. Dr Krop begins with the neoCARHP trial, which reevaluated the role of carboplatin, a component of standard neoadjuvant therapy for patients with early HER2-positive breast cancer. Omitting carboplatin yielded comparable pathologic complete response results confirming noninferiority of the carboplatin-free regimen. Carboplatin was also reexamined in the context of triple-negative breast cancer in the phase 3 NRG-BR003 trial. Invasive disease-free survival rates at 5 years were slightly higher among patients taking carboplatin, although patients who had BRCA mutations appeared to experience more benefit. In hormone receptor (HR)-positive disease, Dr Krop discusses 15-year updated data from the SOFT and TEXT trials assessing the benefit of adjuvant exemestane with ovarian function suppression (OFS) vs tamoxifen plus OFS. Results confirmed the benefit of adding OFS and switching to exemestane, particularly for higher-risk patients. Vasomotor symptoms can compromise quality of life for patients with breast cancer and can lead to nonadherence. Dr Krop highlights the OASIS 4 trial, which evaluated elinzanetant in patients with HR-positive disease. Promising results in this trial are helping to move this therapy toward FDA approval.
Medscape
09-06-2025
- Health
- Medscape
ASCO 2025: Key Updates in Early Breast Cancer Care
Mariana Chavez MacGregor, MD, MSc, comments on how the ASCO 2025 meeting delivered a wealth of impactful data, particularly in the early-stage breast cancer setting. Trials like neoCARHP and CompassHER2 raised important questions about de-escalating therapy for HER2-positive patients, challenging the role of carboplatin and demonstrating strong pathologic complete response rates with shorter regimens. Long-term data from SOFT and TEXT reinforced the survival benefits of ovarian suppression plus an aromatase inhibitor in high-risk premenopausal patients, and the OASIS 4 study showed promise with elinzanetant in managing vasomotor symptoms. Across subtypes, including triple-negative disease, and with the growing role of AI and circulating tumor DNA, the meeting emphasized more personalized, less toxic approaches to care.
