27/08/2026 US FDA granted Fast track designation for Varseta-M in R/R Colorectal Cancer FDA clears path for Phase III melanoma trial of ruxotemitide + pembrolizumab NMPA conditional approval granted for Asandeutertinib in NSCLC with CNS metastases US FDA granted Fast track designation for Varseta-M in R/R Colorectal Cancer (Ref) CytomX Therapeutics announced that the US FDA has granted Fast Track designation to Varsetatug masetecan (Varseta-M; EpCAM targeting ADC) for patient

August 3rd Week, 2026 Special Designations ⭐ The US FDA granted a Fast Track Designation to 858 Therapeutics' ETX-19477 (PARG inhibitor) for the Tx of adults with BRCA‑mutated, HR+/HER2‑ unresectable or metastatic breast cancer (Ref1) ❓ Who are the key competitors to ETX-19477 in the BRCA-m HR+/HER- BC? ⭐ The US FDA granted FTD to BlossomHill Therapeutics, Inc.’s BH-30643 (macrocyclic OMNI-EGFR™ inhibitor) for the Tx of adults with advanced or metastatic EGFR C797S-posit

19/08/2026 Phase 3 INTerpath-001 trial shows individualized mRNA therapy + KEYTRUDA improves survival in resected melanoma Phase 3 INTerpath-001 trial shows individualized mRNA therapy + KEYTRUDA improves survival in resected melanoma (Ref) Merck and Moderna announced that the Phase 3 INTerpath-001 trial evaluating intismeran autogene (V940/mRNA-4157), an individualized mRNA-based neoantigen therapy, in combination with KEYTRUDA® (pembrolizumab. anti-PD-1), achieved its prima

August 1st Week, 2026 Regulatory Events 🎯 The US FDA granted an accelerated approval to Replimune's vusolimogene oderparepvec-wtpg (TUDRIQEVTM/RP1; oncolytic viral therapy) + Bristol Myers Squibb and Ono Pharma's nivolumab (Opdivo; anti-PD-1) for the Tx of adults with unresectable advanced cutaneous melanoma with disease progression on prior anti-PD-1 based regimen (Ref) ❓ How is this approval expected to impact the ≥2L Melanoma Tx paradigm? 🎯 Dr. Reddy's Laboratories ri

July 3rd Week, 2026 Regulatory Events 🎯 The US FDA has accepted Bristol Myers Squibb’s NDA for MeziKd regimen consisting of mezigdomide (cereblon E3 ligase modulator) + carfilzomib (proteasome inhibitor) + dexamethasone (corticosteroid) for RRMM (Ref) ❓ How is MeziKd positioned in the RRMM landscape? 🎯 Eli Lilly and Company's selpercatinib (Retevmo; RET TKI) was granted a traditional full approval by the US FDA for the Tx of adult and pediatric pts aged ≥2 years with L

06/08/2026 US FDA Grants Accelerated Approval for Replimune’s TUDRIQEV + Nivolumab in Advanced Melanoma US FDA Grants Accelerated Approval for Replimune’s TUDRIQEV + Nivolumab in Advanced Melanoma (Ref) Replimune announced that the US FDA has granted accelerated approval for TUDRIQEV™ (vusolimogene oderparepvec-wtpg, formerly RP1; type 1 (HSV-1) oncolytic viral therapy) in combination with nivolumab for patients with unresectable advanced cutaneous Melanoma who have progresse

30/07/2026 NMPA grants priority review to sacituzumab tirumotecan for first‑line TNBC FDA Advisory Committee Backs RP1's Efficacy Data in Advanced Melanoma FDA Grants Orphan Drug Designation to Enzomenib for Acute Lymphoblastic Leukemia REVTORPYK (gedatolisib) Added to NCCN Guidelines for HR+/HER2- Breast Cancer Karyopharm to file sNDA in Aug 2026, for selinexor + ruxolitinib in Myelofibrosis under accelerated approval pathway Selinexor Phase 3 Endometrial cancer trial shows

27/07/2026 Sone‑Ve delivers statistically significant OS benefit in CLDN18.2‑positive gastric/GEJ cancers, while PFS endpoint was not met Philogen resubmits EMA application for Nidlegy with extended Phase III data CG Oncology Publishes Pivotal Phase 3 BOND-003 Cohort C Results in The Lancet Oncology Sone‑Ve delivers statistically significant OS benefit in CLDN18.2‑positive gastric/GEJ cancers, while PFS endpoint was not met (Ref) AstraZeneca's Phase 3 CLARITY-Gastric01 trial

14/07/2026 FDA frants Fast Track Designation to SOTIO’s SOT109 (CDH17-targeting) ADC for advanced Colorectal Cancer FDA grants full approval to selpercatinib for RET fusion positive solid tumors AstraZeneca secures global rights to Zegfrovy, first oral EGFR exon 20 NSCLC therapy, in $600M upfront deal with Dizal In a Ph3 trial, HBI-8000 + nivolumab improved PFS vs nivolumab + placebo, for advanced Melanoma FDA approved first generics of Gilotrif (afatinib) for EGFR‑mutant and

26/06/2026 Henlius’ serplulimab secures EU approval for sqNSCLC FDA accepts RP1 BLA resubmission for advanced Melanoma; Decision expected by August 2026 FDA grants tentative approval for enzalutamide tablets, adding new dosing strengths to compete with Xtandi Henlius’ serplulimab secures EU approval for sqNSCLC (Ref) The European Commission approved serplulimab (Hetronifly®; anti-PD-1) in combination with chemotherapy for first-line treatment of unresectable locally advanced

03/06/2026 Terremoto Biosciences Secures FDA Fast Track for AKT1‑Selective Inhibitor TER‑2013 in HR+/HER2– Breast Cancer FDA grants Orphan Drug Designation to Sotio’s LRRC15-targeted ADC SOT106 for osteosarcoma, advancing toward first-in-human trial in 2H26 Lupin & Natco secure FDA approval for Eribulin generic, unlocking $43.7M U.S. market opportunity Verastem’s VS-7375 secures FDA Fast Track for KRAS G12D-mutated NSCLC Amtagvi® (lifileucel) wins conditional TGA approval as

May 2nd Week, 2026 Regulatory Events 🎯 AstraZeneca and Daiichi Sankyo US’ trastuzumab deruxtecan (HER2 ADC) was approved by the US FDA for both the neoadjuvant and adjuvant Tx of patients with HER2+ early breast cancer (Ref 1) ❓ How does the efficacy and safety shown by the ADC compare to the benchmarks? Special Designations ⭐ The US FDA granted the Fast Track Designation to Alloplex Biotherapeutics Inc’s SUPLEXA (activated patient-derived immune cells) for the Tx of pa

15/05/2026 FDA approved ENHERTU (fam-trastuzumab deruxtecan-nxki) for the treatment of neoadjuvant and adjuvant HER2+ early breast cancer UGN-103 delivers 94.5% six‑month durability in Phase 3 UTOPIA trial, with NDA submission planned for Q3 2026 to advance next‑generation RTGel therapy in recurrent LG‑IR‑NMIBC In Ph3 trial, Regeneron’s fianlimab + cemiplimab showed numeric PFS gain but missed statistical significance vs pembrolizumab in advanced or metastatic Melanoma CAN‑24

06/05/2026 FDA grants Fast Track designation to Diakonos Oncology’s DOC1021 immunotherapy for advanced melanoma, advancing a novel dendritic cell therapy into Phase 1/2 trials Partner Therapeutics secures FDA Priority Voucher for BIZENGRI in NRG1+ cholangiocarcinoma, advancing rapid review of Phase 2 eNRGy data FDA accepts sNDA for IBTROZI® with >4‑year median response in ROS1+ NSCLC, reinforcing long‑term efficacy and global standard‑of‑care potential FDA grants Fast Track d

28/04/2026 FDA accepts NDA for zipalertinib in EGFR exon 20–mutated NSCLC; PDUFA set for Feb 2027 FDA Grants RMAT Designation to Orca-Q, Advancing Precision Cell Therapy for High-Risk Hematologic Malignancies Scancell’s iSCIB1+ secures FDA Fast Track with 77% PFS, Phase 3 initiation anticipated in H2 2026 for advanced Melanoma Henlius secures EU approval for POHERDY® (pertuzumab biosimilar), expanding global oncology footprint FDA accepts NDA for zipalertinib in EGFR exon 20–

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 inhibit

14/04/2026 FDA Grants Fast Track to Daretabart for High‑Risk Neuroblastoma FDA sBLA Submission & NCCN Guideline Inclusion for BIZENGRI in NRG1 Fusion–Positive Cholangiocarcinoma Obsidian Therapeutics and Galera Therapeutics Announce Merger Agreement to advance OBX-115 TIL Therapy FDA Grants Fast Track to Daretabart for High‑Risk Neuroblastoma (Ref) Renaissance Pharma's Daretabart (hu1418K322A), a novel anti-GD2 monoclonal antibody, has received Fast Track status from the U.S.

13/04/2026 FDA issues Complete Response Letter to Replimune’s RP1 BLA, halting accelerated approval path FDA Grants Priority Review for Ifinatamab Deruxtecan in ES-SCLC Daraxonrasib Demonstrates Unprecedented Survival Benefit in Phase 3 Pancreatic Cancer Trial Jaypirca (pirtobrutinib) combination significantly extended progression-free survival (PFS) in Relapsed/Refractory CLL/SLL SynOx Therapeutics' Phase 3 TANGENT Study Delivers Positive Results for TGCT Treatment IDEAYA an

Bristol Myers Squibb's Q4 2025 earnings call spotlighted key milestones for the Opdualag franchise in melanoma 📊 Blockbuster Status and US Dominance Four years post-launch, Opdualag reached blockbuster status with 2025 global revenues of $1,185M, driven by $1,045M in the US. It has captured over 30% US market share, cementing its role as a standard-of-care option for metastatic melanoma. The ex-US market remains largely untapped with sales generating only $140M, constrained

02/02/2026 OS Therapies initiated US FDA BLA filing for OST-HER2 for Osteosarcoma Exelixis' NDA for zanzalintinib + atezolizumab in mCRC has been accepted for review by the US FDA TuHURA Biosciences' IFx-2.0 received the FDA orphan drug designation for cutaneous Melanoma OS Therapies initiated US FDA BLA filing for OST-HER2 for Osteosarcoma (Ref) OS Therapies has initiated a BLA submission to the US FDA for OST-HER2 (HER2-bioengineered form of Listeria monocytogenes) in the p