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Onco-Summaries: Daily Oncology Updates at a Glance
09/03/2026 Johnson & Johnson's AKEEGA regimen received EC approval for the treatment of BRCA1/2-mutated mHSPC BMS announced positive Ph3 data of oral mezigdomide regimen in R/R Multiple Myeloma AstraZeneca and Daiichi Sankyo’s Enhertu received priority review status for HER2-positive early breast cancer Roche announced failure of the Phase 3 persevERA Breast Cancer trial Johnson & Johnson's AKEEGA regimen received EC approval for the treatment of BRCA1/2-mutated mHSPC (Ref)

Oncofocus Team
Mar 102 min read


Onco-Summaries: Daily Oncology Updates at a Glance
23/02/2026 Artios Pharma's ART6043 + olaparib received the FDA fast track designation for breast cancer RYBREVANT SC received EC approval for Q3W and Q4W dosing for EGFR-mutated NSCLC 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-m

Oncofocus Team
Feb 242 min read


Onco-Summaries: Daily Oncology Updates at a Glance
25/11/2025 CStone Pharmaceuticals' sugemalimab received the EC approval for unresectable stage III NSCLC (Ref) The European Commission granted approval to CStone Pharmaceuticals' sugemalimab (anti-PD-L1) as a monotherapy for adult patients with unresectable stage III NSCLC with PD-L1 ≥1% and no sensitising EGFR mutations, or ALK, ROS1 genomic aberrations and whose disease has not progressed following platinum-based chemoradiotherapy. Dr. Jason Yang, CEO, President of R&D, an

Oncofocus Team
Nov 26, 20252 min read


Onco-Summaries: Daily Oncology Updates at a Glance
29/10/2025 Merck's perioperative Keytruda regimen received approval from the EC for LA SCCHN with PD-L1 CPS ≥1 (Ref) The European Commission (EC) has approved Merck & Co./MSD's pembrolizumab (anti-PD-1) single agent as a neoadjuvant Tx followed by adjuvant pembrolizumab + RT with or without cisplatin after surgery, and then as a single agent for adults with resectable locally advanced SCCHN with PD-L1 CPS ≥1. The approval follows a positive CHMP opinion, and is based on resul

Oncofocus Team
Nov 4, 20252 min read


Onco-Summaries: Daily Oncology Updates at a Glance
27/08/2025 BeOne Medicines' perioperative tislelizumab regimen received approval from the EC for resectable NSCLC (Ref) The EC approved BeOne Medicines' tislelizumab (TEVIMBRA; anti-PD-1) + platinum-containing chemotherapy as neoadjuvant treatment followed by tislelizumab monotherapy as adjuvant treatment for adult patients with resectable NSCLC at high risk of recurrence. The approval was based on results from the China-specific Phase 3 RATIONALE-315 trial Per pre-planned fi

Oncofocus Team
Aug 28, 20253 min read


Onco-Summaries: Daily Oncology Updates at a Glance
10/07/2025 TEVIMBRA + chemotherapy has been approved in EU as a first-line treatment for NPC (Ref) The EC approved BeOne Medicines' tislelizumab (TEVIMBRA; anti-PD-1) + gemcitabine + cisplatin for the first-line treatment of adult patients with metastatic or recurrent nasopharyngeal carcinoma (NPC), not amenable to curative surgery or radiotherapy The approval is based on results from the Phase 3 RATIONALE-309 trial which met the primary endpoint of PFS (HR 0.52; p<0.0001)

Oncofocus Team
Jul 11, 20252 min read


Onco-Summaries: Daily Oncology Updates at a Glance
04/07/2025 Imfinzi has been approved by the EC as a perioperative immunotherapy for muscle-invasive bladder cancer (Ref) AstraZeneca’s neoadjuvant durvalumab (Imfinzi; anti-PD-L1) in combination with gemcitabine and cisplatin followed by adjuvant durvalumab monotherapy after radical cystectomy for adult patients with resectable muscle-invasive bladder cancer (MIBC) has been approved in the EU The approval follows the positive CHMP opinion and is based on results from the Phas

Oncofocus Team
Jul 7, 20251 min read
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