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Oncology Updates - Key Oncology News
- Oncofocus Team
- 3 days ago
- 2 min read
May 2nd Week, 2025
Special Designations
⭐ The US FDA granted the Fast Track designation to Adcentrx Therapeutics’ ADRX-0706 (Nectin-4 ADC) for the Tx of locally advanced or metastatic squamous cell cervical cancer. (Ref 1)
❓ What are the outcomes of ADRX-0706 that supported the Fast Track designation?
⭐ The US FDA granted the Fast Track designation to Glenmark Pharmaceuticals (Ichnos Glenmark Innovation)’s ISB2001 (BCMA x CD38 x CD3 trispecific antibody) for the Tx of R/R multiple myeloma patients who have received ≥3 prior lines of Tx including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 mAb. (Ref 2)
❓ What are the key competitors' drugs that have also received the Fast Track designation in this setting?
⭐ The US FDA granted the Fast Track designation to ITALFARMACO S.P.A.’s givinostat (HDAC inhibitor) for the Tx of polycythemia vera. (Ref 3)
❓What are the key unmet needs for patients with polycythemia vera?
Clinical Events
🔬 The Phase 3 DESTINY-Breast11 trial of AstraZeneca and Daiichi Sankyo’s trastuzumab deruxtecan (HER2 ADC) followed by paclitaxel, trastuzumab and pertuzumab achieved a statistically significant pCR rate as a neoadjuvant Tx vs SOC in high-risk, HER2+ve, early-stage breast cancer. (Ref 4)
❓What is the current benchmark for pCR in this indication?
🔬 In the Phase 2b TACTI-003 trial, Immutep Limited's eftilagimod alfa (soluble LAG-3 protein) + MSD/Merck&Co’s pembrolizumab (anti-PD-1) achieved a mOS of 17.6 mos as a first-line Tx of recurrent or metastatic HNSCC with PD-L1 CPS <1. (Ref 5)
❓What are the other LAG-3 agents being evaluated as a first-line Tx for SCCHN?
To know answers to these questions and for additional insights, write to us at support@oncofocus.com
🌐 References:
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