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Oncology Updates - Key Oncology News

July 4th Week, 2025



Regulatory Events 



🎯 The EC approved Bayer and Orion Pharma’s darolutamide (androgen receptor inhibitor) + androgen deprivation therapy for the Tx of metastatic hormone-sensitive prostate cancer. (Ref 1) 


❓ How is this approval going to impact the Tx paradigm of mHSPC? 



🎯 The EC approved Roche's inavolisib (PIK3CA inhibitor) + palbociclib + fulvestrant for the Tx of PIK3CA-mutated, ER+ve, HER2-ve, LA/M breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine Tx. (Ref 2) 


❓ What percentage of breast cancer patients have PIK3CA mutations? 


 

Clinical Events 



🔬 In the Phase 3 FLAURA2 trial, AstraZeneca’s osimertinib (EGFR TKI) + chemotherapy demonstrated a statistically significant and clinically meaningful OS benefit vs osimertinib monotherapy as a first-line Tx of LA/M EGFRm NSCLC. (Ref 3) 


❓ How is the OS data going to impact the competitive position of the regimen? 



Special Designations 



⭐ The US FDA granted the Breakthrough Therapy Designation to Revolution Medicines' elironrasib (RAS(ON) G12C inhibitor) for the Tx of KRAS G12C-mutated, LA/M NSCLC who have received prior chemotherapy and IO but have not been previously treated with a KRAS G12C inhibitor. (Ref 4) 


❓ What are the key unmet needs for this indication? 


 

⭐ The US FDA granted the Fast Track Designation to Duality Biologics' DB-1310 (HER3 ADC) for the Tx of advanced, unresectable or metastatic non-sqNSCLC with an EGFR exon 19 deletion or L858R mutation with disease progression on or after Tx with a 3rd gen. EGFR TKI and platinum-based chemotherapy. (Ref 5) 


❓ What are the clinical outcomes that support the FTD? 


 

⭐ The US FDA granted the Fast Track Designation to GenFleet Therapeutics and Verastem Oncology's VS-7375 (KRAS G12D (ON/OFF) inhibitor) for the first-line Tx of KRAS G12D-mutated, LA/M adenocarcinoma of the pancreas, and for the Tx of KRAS G12D-mutated, LA/M PDAC who have received at least one prior line of standard systemic therapy. (Ref 6) 


❓ Which other KRAS inhibitors are currently being developed for these indications? 


 

Setbacks 



🛑 The US FDA issued a CRL regarding the BLA for Replimune's vusolimogene oderparepvec (RP1; herpes simplex virus engineered with a fusogenic protein (GALV-GP R-) and GM-CSF) + nivolumab for the Tx of advanced melanoma. The CRL highlighted that the FDA was unable to approve the application in its present form. (Ref 7) 


❓ How will the setback impact Replimune’s pipeline and launch plans? 


 

To know answers to these questions and for additional insights, write to us at support@oncofocus.com. 



🌐 References: 



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