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Oncology Updates - Key Oncology News
- Oncofocus Team
- Jun 23
- 2 min read
March 3rd Week, 2025
Regulatory Events
🎯 The US FDA granted traditional approval to Merck & Co./MSD’s pembrolizumab (anti-PD-1) + trastuzumab (anti-HER2) + fluoropyrimidine- and platinum-containing chemo for the first-line treatment of adults with locally advanced, unresectable/metastatic HER2+ve gastric/gastroesophageal junction adenocarcinoma with PD-L1 CPS ≥1 (Ref 1). The regimen was previously granted accelerated approval for this indication in May’21.
❓ Which other regimens have been approved for these patients? Which pipeline regimen has potential to challenge the current SOCs?
🎯 Akeso Biopharma & Chia Tai Tianqing Pharmaceutical Group Co., Ltd.’s penpulimab (anti-PD-1) + chemotherapy has been approved by China’s NMPA for the first-line treatment of recurrent or metastatic nasopharyngeal cancer. (Ref 2)
❓ Does penpulimab + chemo have the potential to become the go-to treatment option for first-line nasopharyngeal cancer patients?
🎯 AstraZeneca & Daiichi Sankyo’s datopotamab deruxtecan (anti-TROP2 ADC) has been launched in Japan for the treatment of adult patients with HR+ve, HER2-ve, unresectable or recurrent breast cancer after prior chemotherapy. (Ref 3)
❓ How do the outcomes of datopotamab deruxtecan compare against the existing therapies in the market?
Special Designations
⭐ The US FDA has granted orphan drug designations to multiple assets including PEP-Therapy's PEP-010 (bi-functional peptide) for pancreatic cancer (Ref 4), Onconic Therapeutics’ nesuparib (PARP1/2/TNK1/2 inhibitor) for gastric/gastroesophageal junction cancer (Ref 5), and Shanghai Henlius Biotech’s HLX22 (anti-HER2) for gastric cancer (Ref 6).
❓ What is the competitive position of these assets in their respective pipeline landscapes?
⭐ The Center for Drug Evaluation (CDE) of China’s NMPA has granted the breakthrough-therapy designation to Alphamab Oncology and CSPC Pharmaceutical Group 's JSKN003 (anti-HER2 biparatopic ADC) for the treatment of platinum-resistant, recurrent epithelial ovarian cancer, primary peritoneal cancer, and fallopian tube cancer. (Ref 7)
❓ What are the outcomes of JSKN003 that supported the breakthrough-therapy designation?
To know answers to these questions and for additional insights, write to us at support@oncofocus.com.
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