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Onco-Summaries: Daily Oncology Updates at a Glance
- Oncofocus Team
- 6 days ago
- 2 min read
24/02/2026
Pfizer's encorafenib + cetuximab + chemo received FDA traditional approval for CRC (Ref)
The US FDA granted traditional approval to Pfizer's encorafenib (BRAF inhibitor) + cetuximab + fluorouracil-based chemotherapy for the treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation, as detected by an FDA-authorized test.
The approval has been granted based on results from the Phase 3 BREAKWATER trial (NCT04607421), a randomized, active-controlled, open-label, multicenter study in patients with treatment-naïve, BRAF V600E mutation–positive, metastatic CRC
Encorafenib had received accelerated approval in combination with cetuximab and mFOLFOX6 for metastatic colorectal cancer with BRAF V600E mutation in 2024
Siren Biotechnology's SRN-101 received the FDA fast track designation for HGG (Ref)
The US FDA granted the fast track designation to Siren Biotechnology's SRN-101 (AAV-based immuno-gene therapy) for the treatment of recurrent high-grade glioma (HGG).
Siren recently announced FDA clearance of its first IND filing for SRN-101, enabling first-in-human clinical evaluation in patients with recurrent high-grade glioma
Aktis Oncology's AKY-1189 received the FDA fast track designation for mUC (Ref)
The US FDA granted the fast track designation to Aktis Oncology's AKY-1189 (alpha-emitting radiopharmaceutical targeting Nectin-4) for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who have progressed on or after prior systemic therapies.
Aktis is currently conducting a multi-site Phase 1b clinical trial (NCT07020117) of AKY-1189 in the United States for the treatment of locally advanced or mUC, breast cancer, non-small cell lung cancer, colorectal cancer, cervical cancer, and head and neck cancer
Aktis expects to present preliminary results from Part 1 of the trial in the first quarter of 2027
Onconic Therapeutics' nesuparib received the FDA orphan drug designation for SCLC (Ref)
The US FDA granted the orphan drug designation to Onconic Therapeutics' nesuparib (dual inhibitor of PARP and TNKS) for the treatment of small cell lung cancer.
"The FDA highly valued the potential of nesuparib's dual mechanism in suppressing two core survival axes of cancer cells. We expect the drug to offer a new alternative for patients with recurrent or treatment-resistant small cell lung cancer," an Onconic Therapeutics official said.
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