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Oncology Updates - Key Oncology News
- Oncofocus Team
- 3 days ago
- 2 min read
June 2nd Week, 2025
Regulatory Events
🎯 The US FDA approved Merck & Co./MSD's pembrolizumab (anti-PD-1) mono Q3W, 2Cy, as a neoadjuvant Tx followed by adjuvant pembro Q3W, 3Cy + RT ± cisplatin after surgery, then pembro mono Q3W, 12Cy, for adults with resectable locally advanced SCCHN with PD-L1 CPS ≥1. (Ref 1)
❓ What were the factors that influenced the FDA’s decision to limit the label to PD-L1 CPS ≥1?
🎯 The US FDA approved Nuvation Bio’s taletrectinib (ROS1 inhibitor) for the Tx of adult patients with locally advanced or metastatic ROS1+ve NSCLC. (Ref 2)
❓ How is this approval going to impact the Tx paradigm of ROS1+ve NSCLC?
🎯 The US FDA approved UroGen Pharma’s Zusduri (mitomycin and sterile hydrogel) for the Tx of adults with recurrent Low-Grade Intermediate-Risk NMIBC. (Ref 3)
❓ What are the key unmet needs of recurrent LG-IR-NMIBC?
🎯 The US FDA approved BeOne Medicines’ new tablet formulation of zanubrutinib (small molecule inhibitor of BTK) for all five previously approved indications. (Ref 4)
❓ What are the pros and cons of the tablet formulation of zanubrutinib?
Special Designations
⭐ The US FDA accepted Jazz Pharmaceuticals’ sNDA for lurbinectedin (DNA alkylating agent) + Roche’s atezolizumab (anti-PD-L1) as a first-line maintenance Tx for extensive-stage SCLC patients whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin, and etoposide for Priority Review, with a PDUFA action date of Oct 7, 2025. (Ref 5)
❓ What are the clinical outcomes of the combination that support the priority review?
⭐ The US FDA granted Fast Track Designation to Cantargia AB’s nadunolimab (anti-IL1RAP) + gemcitabine and nab-paclitaxel for the Tx of patients with previously untreated metastatic pancreatic ductal adenocarcinoma with high IL1RAP expression. (Ref 6)
❓ How do the outcomes of the combination compare against the current benchmarks?
⭐ The US FDA granted Fast Track Designation to Radiopharm Theranostics’ RAD101 (imaging small molecule targeting FASN) to distinguish between recurrent disease and treatment effect of brain metastases originating from solid tumors of different origin including leptomeningeal disease. (Ref 7)
❓ Who are the other key players with assets that have received the FTD for the imaging of brain metastases?
To know answers to these questions and for additional insights, write to us at support@oncofocus.com.
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