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Oncology Updates - Key Oncology News
- Oncofocus Team
- Oct 3, 2025
- 2 min read
September 4th Week, 2025
🎯 The US FDA approved Eli Lilly and Company's imlunestrant (oral estrogen receptor antagonist) for the Tx of adults with ER+, HER2–, ESR1-mutated advanced or metastatic breast cancer whose disease progressed after at least one line of endocrine therapy. (Ref 1)
❓ How is this approval expected to impact the Tx paradigm?
🎯 Nuvalent, Inc., completed its NDA submission to the US FDA for zidesamtinib (ROS1-selective macrocyclic tyrosine kinase inhibitor) in TKI pre-treated patients with advanced ROS1 positive NSCLC. (Ref 2)
❓ What were the clinical outcomes that supported the submission?
🎯 China's NMPA accepted Kelun-Biotech's NDA for A400/EP0031 (RET kinase inhibitor) for the Tx of adult patients with RET-fusion positive locally advanced, or metastatic NSCLC. (Ref 3)
❓ What is the development status of the asset in other key geographies?
🔬 Bristol Myers Squibb's Phase 3 EXCALIBER-RRMM trial of iberdomide (cereblon E3 ligase modulator) + daratumumab + dexamethasone demonstrated a statistically significant improvement in MRD negativity rates vs control arm in patients with R/R multiple myeloma. (Ref 4)
❓ What are the current benchmarks in this indication?
⭐ The US FDA accepted and granted Priority Review to AstraZeneca and Daiichi Sankyo’s sBLA for trastuzumab deruxtecan (HER2 ADC) + pertuzumab for the first-line Tx of adult patients with unresectable or metastatic HER2 positive breast cancer. (Ref 5)
❓ Which other ADCs are being developed for this indication?
⭐ The US FDA granted the fast-track designation to Artios' alnodesertib (ATR inhibitor) + low dose irinotecan (chemotherapeutic agent) for the Tx of adult patients with ATM-negative metastatic colorectal cancer in the third-line setting. (Ref 6)
❓ Which other promising assets are in pipeline for 3L CRC?
⭐ The US FDA granted the orphan drug designation to Biostar Pharma, Inc.’s utidelone (microtubule inhibitor) for the Tx of pancreatic cancer. (Ref 7)
❓ What are the key unmet medical needs of this indication?
To know answers to these questions and for additional insights, write to us at support@oncofocus.com.
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