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Onco-Summaries: Daily Oncology Updates at a Glance
- Oncofocus Team
- Feb 24
- 2 min read
23/02/2026
Artios Pharma's ART6043 + olaparib received the FDA fast track designation for breast cancer (Ref)
The US FDA granted the Fast Track designation to Artios Pharma's ART6043 (DNA polymerase theta (Polθ) inhibitor) + olaparib (PARP inhibitor) for the treatment of adult patients with germline BRCA-mutated, HER2-ve, locally advanced or metastatic breast cancer who have received no prior treatment with a PARP inhibitor.
The designation has been granted based on data from the ongoing, first-in-human, Phase 1/2a study (NCT05898399)
This designation will enable Artios to interact more frequently and earlier with the FDA to discuss ART6043’s development path
RYBREVANT SC received EC approval for Q3W and Q4W dosing for EGFR-mutated NSCLC (Ref)
The EC has approved an extension of Johnson & Johnson's RYBREVANT (amivantamab) marketing authorisation to include additional subcutaneous (SC) dosing regimens. With this decision, SC amivantamab is now authorised for use across all previously approved intravenous (IV) amivantamab indications, including:
Every-four-week (Q4W) SC amivantamab dosing regimen:
In combination with lazertinib for first-line treatment of adult patients with advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations
As monotherapy for adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after failure of platinum-based therapy
Every-three-week (Q3W) SC amivantamab dosing regimen in combination with carboplatin and pemetrexed for adult patients with advanced NSCLC:
With EGFR exon 19 deletions or exon 21 L858R substitution mutations after failure of prior therapy, including an EGFR tyrosine kinase inhibitor (TKI)
With activating EGFR exon 20 insertion mutations, as first-line treatment
The approval is supported by results from the Phase 2 PALOMA-2 and Phase 1 PALOMA studies
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