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Oncology Updates - Key Oncology News
- Oncofocus Team
- 2 days ago
- 2 min read
February 1st Week, 2026
🎯 The US FDA approved an update to Gilead Sciences' axicabtagene ciloleucel (anti-CD19 CAR-T) prescribing information removing the previous “Limitations of Use” in patients with relapsed/refractory primary central nervous system lymphoma (Ref 1)
❓ How would this decision alter Yescarta’s positioning in the market landscape?
🎯 AstraZeneca and Daiichi Sankyo US’ sBLA for datopotamab deruxtecan (TROP2 ADC) was accepted and granted a Priority Review in the US for the Tx of unresectable/metastatic triple-negative breast cancer patients who are not candidates for PD-(L)1 inhibitors (Ref 2)
❓ What are the clinical outcomes supporting this Priority review?
🎯 OS Therapies has initiated a BLA submission to the US FDA for OST-HER2 (HER2 targeted vaccine) in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma (Ref 3)
❓ What is the current SOC for osteosarcoma?
🎯 The US FDA has accepted Exelixis' NDA for zanzalintinib (multi-TKI) + Roche's atezolizumab (anti-PD-L1) for the Tx of adults with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemo, and, if RAS WT, an anti-EGFR (Ref 4)
❓ How does zanzalintinib compare to other key late-stage assets being developed for mCRC?
⭐ The US FDA granted the orphan drug designation to Partner Therapeutics' zenocutuzumab (HER2xHER3 BsAb) for the Tx of advanced unresectable/metastatic cholangiocarcinoma (Ref 5)
❓ Which other HER2 targeting therapies are being developed for this indication?
⭐ The US FDA granted the fast-track designation to Oncolytics Biotech Inc.'s pelareorep (oncolytic virus) + bevacizumab + FOLFIRI for KRAS-mutant, MSS mCRC in the second-line setting (Ref 6)
❓ Which are the key promising assets in this indication?
⭐ The US FDA granted the breakthrough therapy designation to Relay Therapeutics' zovegalisib (PI3Kα inhibitor) + fulvestrant for the Tx of PIK3CA mutant, HR +, HER2-, LA/M breast cancer following recurrence or progression on or after Tx with a CDK4/6 inhibitor (Ref 7)
❓ What are the launch timeline estimates for this regimen?
⭐ The US FDA granted the orphan drug designation to TuHURA Biosciences, Inc.' IFx-2.0 (innate immune agonist) for the Tx of stage IIB-IV cutaneous melanoma (Ref 8)
❓ 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.
🌐 References:
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