University Hospital Erlangen
🇩🇪Germany
- Country
- 🇩🇪Germany
- Ownership
- Private
- Established
- 1815-01-01
- Employees
- 5K
- Market Cap
- -
- Website
- http://www.uk-erlangen.de
Kisqali and Itovebi Secure FDA Approval for Advanced Breast Cancer Treatment
• Ribociclib (Kisqali) gains FDA approval in combination with aromatase inhibitors for adjuvant treatment of HR+/HER2- early breast cancer, reducing recurrence risk.
• Inavolisib (Itovebi) receives FDA approval when combined with palbociclib and fulvestrant for endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative advanced breast cancer.
• The approvals offer new treatment options for a broader range of breast cancer patients, addressing unmet needs and improving care approaches.
Kisqali Demonstrates Sustained Benefit in Early Breast Cancer
• Updated analysis of the NATALEE trial shows Kisqali plus endocrine therapy reduces recurrence risk by 28.5% in stage II and III HR+/HER2- early breast cancer.
• The invasive disease-free survival benefit of Kisqali was consistent across all pre-specified patient subgroups, including node-negative disease.
• Secondary endpoints, including distant disease-free survival, also showed consistent results, with a trend for improved overall survival.
• The safety profile of Kisqali remains consistent with previous reports, showing a well-tolerated profile with generally low-grade adverse events.
Kisqali Deepens Benefit in Early Breast Cancer, Reducing Recurrence Risk by 28.5%
• Updated analysis of the Phase III NATALEE trial shows Kisqali plus endocrine therapy reduces the risk of breast cancer recurrence by 28.5% compared to endocrine therapy alone.
• The invasive disease-free survival benefit of Kisqali was consistent across all pre-specified patient subgroups, including those with node-negative disease.
• Secondary endpoints, including distant disease-free survival, also showed consistent results, with a trend for improved overall survival.
• Safety profile of Kisqali remains consistent with previous reports, with generally low-grade symptomatic adverse events.
Optoacoustic Imaging Shows Promise for Non-Invasive Pompe Disease Monitoring
• Researchers have demonstrated that multispectral optoacoustic tomography (MSOT) can non-invasively assess glycogen storage and muscle degeneration in Pompe disease.
• The study utilized MSOT to image the biceps of late-onset Pompe disease patients, revealing distinct optoacoustic signatures compared to healthy volunteers.
• MSOT data correlated with clinical assessments and MRI findings, suggesting its potential as a valuable tool for monitoring disease progression and treatment response.
• This non-invasive approach offers a radiation-free alternative to traditional methods, potentially improving patient monitoring and clinical trial outcomes.
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