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Oncology Updates - Key Oncology News
- Oncofocus Team
- 12 hours ago
- 2 min read
February 2nd Week, 2026
Regulatory Events
🎯 The US FDA approved Merck & Co/MSD's Keytruda (pembrolizumab; anti-PD-1) as well as Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph subcutaneous product) in combination with paclitaxel, with or without bevacizumab, for adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS≥1), and who have received one or two prior systemic treatment regimens. (Ref 1)
❓ What are the clinical outcomes that support this approval?
🎯 The US FDA completed its filing review and accepted filing of Biofrontera Inc.'s sNDA for Ameluz (aminolevulinic acid hydrochloride) topical gel used in combination with the RhodoLED® red-light lamp series for the treatment of Superficial Basal Cell Carcinoma. (Ref 2)
❓ What is the current SOC for sBCC?
Special Designations
⭐ The US FDA granted the Fast Track Designation to Abbisko Therapeutics' (和誉医药) irpagratinib (FGFR4 inhibitor) for the treatment of patients with hepatocellular carcinoma with FGF19 overexpression who have been previously treated with ICIs and multi-TKl therapies. (Ref 3)
❓ Which are the key promising assets in the HCC pipeline landscape?
⭐ The US FDA granted the Orphan Drug Designation to HanchorBio Inc. 漢康生技股份有限公司's HCB101 (CD47–SIRPα pathway inhibitor) for the treatment of gastric cancer. (Ref 4)
❓ What are the key unmet medical needs of this indication?
⭐ The US FDA granted the Regenerative Medicine Advanced Therapy (RMAT) Designation to Krystal Biotech, Inc.'s KB707 (redosable immunotherapy designed to drive sustained, localized expression of interleukin-2 and interleukin-12 in the tumor microenvironment) for the treatment of advanced or metastatic NSCLC. (Ref 5)
❓ What are the launch timeline estimates for this regimen?
Setbacks
🛑 AstraZeneca announced the discontinuation of the Daiichi Sankyo US -partnered Phase 3 TROPION-Lung12/NCT06564844 trial of datopotamab deruxtecan (TROP2 ADC) + rilvegostomig (PD-1 x TIGIT BsAb) or rilvegostomig mono vs standard of care in stage I adenocarcinoma NSCLC who are ctDNA-positive or have high-risk pathological features (Ref 6)
❓ How are key competitors positioned in the development landscape for adjuvant NSCLC?
To know answers to these questions and for additional insights, write to us at support@oncofocus.com.
🌐 References:
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