Oncology Updates - Key Oncology News

April 3rd Week, 2026

Regulatory Events 

🎯 The BLA for Merck & Co./MSD and Daiichi Sankyo US’ ifinatamab deruxtecan (I-DXd; B7-H3 ADC) has been accepted and granted Priority Review by the US FDA for extensive-stage SCLC patients whose disease progressed after platinum-based chemo (Ref 1) 

❓ Who are the key competitors to I-DXd in the ES-SCLC market landscape?

Special Designations 

⭐ The US FDA granted the Fast Track Designation to Opna Bio’s OPN-6602 (dual EP300/CBP inhibitor) for treating R/R multiple myeloma in patients who have undergone at least four prior lines of therapy (Ref 2) 

❓ What is the addressable market size for OPN-6602? 

⭐ Renaissance Pharma Ltd's daretabart (anti-GD2) was granted the FDA Fast Track Designation for treating high-risk neuroblastoma (Ref 3) 

❓ What is the current SOC for high-risk neuroblastoma? 

⭐ Immutep Limited’s eftilagimod alfa (soluble LAG-3 protein) received the FDA Orphan Drug Designation for soft tissue sarcoma (Ref 4) 

❓ What are the key unmet medical needs of this indication? 

Clinical Events 

🔬 Positive topline results were announced from the Phase 3 RASolute 302 trial of Revolution Medicines’ daraxonrasib (RAS(ON) multi-select inibitor) vs chemotherapy in previously treated metastatic pancreatic ductal adenocarcinoma (Ref 5) 

❓ What is the efficacy and safety benchmark in pre-treated PDAC? 

🔬 Top‑line result from Eli Lilly and Company’s Phase 3 BRUIN CLL‑322 trial showed the study’s primary endpoint being met, with pirtobrutinib (Jaypirca; BTK inhibitor) + venetoclax (BCL2 inhibitor) + rituximab (anti-CD20) significantly extending PFS vs venetoclax‑rituximab alone in R/R chronic lymphocytic leukemia or small lymphocytic lymphoma (Ref 6) 

❓ How is the regimen positioned in the current CLL/SLL development landscape? 

🔬 SynOx Therapeutics' emactuzumab (short-course CSF-1R inhibitor) has successfully met all primary and secondary endpoints in its pivotal Phase 3 TANGENT trial for Tenosynovial Giant Cell Tumor (TGCT) (Ref 7)

❓ What is the current market landscape of TGCT?

🔬 The Phase 2/3 OptimUM-02 trial of IDEAYA Biosciences and Servier’s darovasertib (PKC inhibitor) + Pfizer’s crizotinib (kinase inhibitor) in first-line HLA-A*02:01-negative metastatic uveal melanoma met its primary endpoint with a statistically significant improvement in PFS observed vs investigator’s choice of therapy. (Ref 8)

❓ What are the emerging treatment strategies for uveal melanoma? 

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

🌐 References: 

1) https://daiichisankyo.us/press-releases/-/article/ifinatamab-deruxtecan-granted-priority-review-in-the-us-for-adult-patients-with-previously-treated-extensive-stage-small-cell-lung-cancer-who-experienced-disease-progression-on-or-after-platinum-based-chemotherapy

2) https://www.opnabio.com/opna-bio-announces-fast-track-designation-granted-to-opn-6602-for-the-treatment-of-multiple-myeloma/

3) https://www.renaissancepharma.co.uk/fda-fast-track-designation

4) https://www.immutep.com/immutep-receives-fda-orphan-drug-designation-for-eftilagimod-alfa-in-soft-tissue-sarcoma/

5) https://ir.revmed.com/news-releases/news-release-details/daraxonrasib-demonstrates-unprecedented-overall-survival-benefit

6) https://investor.lilly.com/news-releases/news-release-details/lillys-jaypirca-pirtobrutinib-significantly-extended-progression

7) https://synoxtherapeutics.com/synox-therapeutics-announces-positive-topline-results-from-the-phase-3-tangent-study/

8) https://media.ideayabio.com/2026-04-13-IDEAYA-Biosciences-and-Servier-Announce-Positive-Topline-Results-from-Phase-2-3-Registrational-Trial-OptimUM-02-of-Darovasertib-in-Combination-with-Crizotinib-in-First-line-HLA-A-02-01-Negative-Metastatic-Uveal-Melanoma