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Oncology Updates - Key Oncology News
- Oncofocus Team
- Jul 14
- 2 min read
Updated: Jul 21
July 2nd Week, 2025
Regulatory Updates
🎯 The EC approved BeOne Medicines' tislelizumab (anti-PD-1) + gemcitabine + cisplatin for the first-line Tx of metastatic or recurrent nasopharyngeal carcinoma (NPC), not amenable to curative surgery or radiotherapy. (Ref 1)
❓ What are the other key Asia-specific trials emerging in this indication?
🎯 The UK’s MHRA granted marketing authorization to ImmunityBio, Inc.'s nogapendekin alfa inbakicept-pmln (lymphocyte-stimulating agent) + BCG for the Tx of BCG-unresponsive NMIBC Carcinoma In Situ. (Ref 2)
❓ What are the clinical outcomes that support this approval?
🎯 The US FDA approved Sirtex Medical Limited's SIR-Spheres Y-90 resin microspheres for the Tx of unresectable HCC. (Ref 3)
❓ How does this therapy compare against the existing SOC options?
Special Designations
⭐ The US FDA granted the Breakthrough Device designation to ArteraAI's ArteraAI Prostate (an AI precision medicine tool) intended to assist clinicians with risk-based decisions for patients with localized prostate cancer. (Ref 4)
❓ Who are the other key players developing similar AI tools?
⭐ The US FDA granted the Fast Track designation to Trethera's TRE-515 (dCK inhibitor) + radioligand therapy for the Tx of PSMA+ve metastatic CRPC. (Ref 5)
❓ What are the key unmet needs for this indication?
⭐ The US FDA granted the Orphan Drug designation to Arcus Biosciences' quemliclustat (CD73 inhibitor) for the Tx of pancreatic cancer. (Ref 6)
❓ Which are the key assets in the competitive landscape for pancreatic cancer?
Deal and Collaborations
🤝 Adagene announced a partnership with Conjugate Bio to provide a proprietary antibody for use in partner companies’ bispecific ADC development programs. Under the terms of the agreement, Adagene will receive an undisclosed upfront payment, as well as milestone and royalty payments, and will provide an internally developed antibody for novel bispecific ADC development. (Ref 7)
❓ Which other companies have promising bispecific ADCs?
🤝 CARGO Therapeutics entered into a definitive merger agreement with Concentra Biosciences, whereby Concentra will acquire CARGO for $4.379 in cash per share of CARGO common stock, par value $0.001 per share, plus one non-transferable contingent value right. The merger transaction is expected to close in August 2025. (Ref 8)
❓ Which are the key assets of interest from CARGO’s pipeline?
To know answers to these questions and for additional insights, write to us at support@oncofocus.com
🌐 References:
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