July 5th Week, 2026 Regulatory Events 🎯 Marketing Authorization Application (MAA) for Philogen S.p.A. and SUN PHARMA’s daromun (Nidlegy™; L19IL2 and L19TNF combination) for the neoadjuvant Tx of locally advanced, fully resectable melanoma was resubmitted to the EMA (Ref) ❓ What are the clinical benchmarks for resectable melanoma Tx in the EU? 🎯 Replimune announced a favorable outcome from the US FDA's Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) meetin

June 1st Week, 2026 Regulatory Updates 🎯 Australia’s Therapeutic Goods Administration (TGA) has conditionally approved Iovance Biotherapeutics, Inc.'s lifileucel (Amtagvi®; tumor infiltrating lymphocytes), making it the first T cell therapy for a solid tumor and the first treatment option in Australia for advanced melanoma in adults, after anti‑PD‑1 and targeted therapy (Ref) ❓ Which other regimens have the potential to challenge lifileucel in this setting? 🎯 The U

02/09/2025 Replimune has scheduled a Type A Meeting with the FDA for the CRL of RP1 + nivo in advanced melanoma (Ref) Replimune announced that a Type A meeting with the US FDA has been scheduled to discuss the CRL for the BLA of vusolimogene oderparepvec (RP1; herpes simplex virus engineered and genetically armed with GALV-GP R- and GM-CSF) + nivolumab for the treatment of advanced melanoma. Replimune submitted a briefing book to the FDA addressing the points from the CRL T

April 3rd Week, 2025 Regulatory Events 🎯 Bristol Myers Squibb’s nivolumab (anti-PD-1) + ipilimumab (anti-CTLA-4) has been approved by the US FDA as a first-line Tx of unresectable/metastatic hepatocellular carcinoma. (Ref 1) ❓ What portion of the first-line HCC patients are anticipated to transition to the nivolumab + ipilimumab regimen? 🎯 ImmunityBio, Inc. completed the sBLA submission to the US FDA for nogapendekin alfa inbakicept (IL-15 superagonist fusion protein) + B

April 1st Week, 2025 Regulatory Events 🎯 AstraZeneca's neoadjuvant durvalumab (anti-PD-L1) + chemo followed by adjuvant durvalumab mono has been approved for adults with resectable NSCLC at a high risk of recurrence and no EGFR mutations or ALK rearrangements in the EU. (Ref 1) ❓ What are the other approved regimens in the early-stage NSCLC, and how do the outcomes of the AEGEAN regimen compare against those regimens? 🎯 The US FDA approved AstraZeneca’s neoadjuvant durval