Oncology Updates - Key Oncology News
- Oncofocus Team
- Aug 13
- 2 min read
July 4th Week, 2026
Regulatory Events
🎯 GSK's zidesamtinib (Jideytro; ROS1 selective inhibitor) was approved by the US FDA for the Tx of adults with LA/M ROS1-positive NSCLC who have previously received a ROS1 kinase inhibitor (Ref)
❓ How is GSK positioned in the ROS1 NSCLC market landscape?
🎯 The US FDA has granted Priority Review for a supplemental NDA of Pfizer’s talazoparib (TALZENNA; PARP inhibitor) + Pfizer and Astellas Pharma's enzalutamide (XTANDI; androgen receptor pathway inhibitor) in homologous recombination repair (HRR) gene-mutated metastatic castration-sensitive prostate cancer (mCSPC), with PDUFA date in Q4'26 (Ref)
❓ What is the addressable market for HRR-mutated CSPC in the US?
🎯 Revolution Medicines' NDA for daraxonrasib (RAS(ON) multi-selective inhibitor) for previously treated metastatic pancreatic ductal adenocarcinoma (PDAC) was accepted for review by the US FDA under the FDA Commissioner’s National Priority Voucher pilot program (Ref)
❓ What is the current SOC for previously treated PDAC?
🎯 China's NMPA has accepted Shanghai Junshi Biosciences Co Ltd’s supplemental application for toripalimab + platinum chemotherapy as perioperative treatment (plus adjuvant monotherapy) for resectable stage II–III NSCLC patients, expanding the approved indication from resectable stage IIIA–IIIB NSCLC (Ref)
❓ What is the current SOC for resectable NSCLC in China?
Clinical Events
🔬 Positive topline results from the Ph3 MonumenTAL-6 trial of Johnson & Johnson Innovative Medicine's teclistamab-cqyv (TECVAYLI; CD3 x BCMA bispecific TCE) + talquetamab-tgvs (TALVEY; CD3 x GPRC5D bispecific TCE) and talquetamab-tgvs + pomalidomide combinations in R/R multiple myeloma patients demonstrated statistically significant and clinically meaningful PFS and OS improvements for both investigational arms compared with investigator’s choice SOC (Ref)
❓ What were the POC clinical outcomes for this regimen in R/R MM?
🔬 Per updated analysis from the Ph3 HARMONi trial, Summit Therapeutics, Inc. and Akeso Biopharma's ivonescimab (PD-1 x VEGF BsAb) + chemotherapy continued to outperform chemotherapy alone in EGFR-mutated non-squamous NSCLC patients previously treated with a third-generation EGFR TKI (Ref)
❓ How is ivonescimab positioned in the EGFR-mutant NSCLC developmental landscape?
To know answers to these questions and for additional insights, write to us at support@oncofocus.com.
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