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Oncology Updates - Key Oncology News
- Oncofocus Team
- Mar 19
- 2 min read
March 2nd Week, 2026
Regulatory Events
🎯 The EC has approved an indication extension for Johnson & Johnson Innovative Medicine's AKEEGA® (niraparib and abiraterone acetate dual action tablet) with prednisone or prednisolone in combination with androgen deprivation therapy, for the treatment of patients with metastatic hormone-sensitive prostate cancer and BRCA1/2 mutations (germline and/or somatic). (Ref 1)
❓ How do the outcomes of this regimen compare against the other approved agents?
🎯 The US FDA accepted and granted Priority Review to AstraZeneca and Daiichi Sankyo US’ sBLA for Enhertu (trastuzumab deruxtecan) for the treatment of adult patients with HER2-positive breast cancer who have residual invasive disease after neoadjuvant HER2-targeted treatment. (Ref 2)
❓ What are the clinical outcomes that support this filing?
Clinical Events
🔬 Bristol Myers Squibb's Phase 3 SUCCESSOR-2 trial of oral mezigdomide in combination with carfilzomib and dexamethasone demonstrated statistically significant and clinically meaningful improvement in PFS vs carfilzomib and dexamethasone alone in patients with R/R multiple myeloma. (Ref 3)
❓ What are the launch timeline estimates for this regimen?
Special Designations
⭐ The US FDA granted the orphan drug designation to Aminex Therapeutics' AMXT 1501 (polyamine transport inhibitor) + difluoromethylornithine for the treatment of malignant glioma, including diffuse intrinsic pontine glioma. (Ref 4)
❓ What are the key unmet medical needs of this indication?
Setbacks
🛑 Roche's Phase 3 persevERA Breast Cancer trial evaluating giredestrant + palbociclib in ER-positive, HER2-negative, locally advanced or metastatic breast cancer patients did not meet its primary objective of a statistically significant improvement in PFS vs letrozole + palbociclib (Ref 5)
❓ Which are the other key Phase 3 trials ongoing in this indication?
🛑 Based on the Independent Data Monitoring Committee recommendation, Immutep Limited's Phase 3 TACTI-004 trial of eftilagimod alfa (LAG-3 MHC Class II agonist) + pembrolizumab + chemo regimen as a first-line treatment of NSCLC has been discontinued. (Ref 6)
❓ Which are the other active LAG-3 agents under development?
To know answers to these questions and for additional insights, write to us at support@oncofocus.com.
🌐 References:
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