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 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 patients with relapsed/refractory metastatic colorectal cancer (R/R mCRC), based on encour

26/08/2026 US FDA Fast Track designation granted for SOT106 in Soft Tissue Sarcoma; First-in-Human Trial Planned in late-2026 US FDA Fast Track designation granted for SYS6090 in MSS/pMMR metastatic colorectal cancer Celcuity submits sNDA to US FDA for approval of gedatolisib combination therapy in PIK3CA-mutant HR+/HER2- advanced breast cancer US FDA Fast Track designation granted for SOT106 in Soft Tissue Sarcoma; First-in-Human Trial Planned in late-2026 (Ref) The US FDA h

25/08/2026 US FDA approves zanidatamab combination therapy in HER2+ GEA US FDA approves zanidatamab combination therapy in HER2+ GEA (Ref) The US FDA has approved Jazz, BeOne and Zymeworks' Ziihera (zanidatamab-hrii; bispecific HER2-directed antibody) with and without BeOne's tislelizumab (anti-PD-1) + chemotherapy for first-line treatment of HER2+ advanced gastroesophageal adenocarcinoma (GEA), regardless of PD-L1 status Approval was supported by Phase 3 HERIZON-GEA-01 trial

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

24/08/2026 EC Expands Trodelvy + Keytruda Approval to First-Line Metastatic TNBC Across PD-L1 Status US FDA accepts Jemperli for priority review in dMMR/MSI-H rectal cancer US FDA Fast Track designation granted for ERAS-0015 in metastatic pancreatic cancer; Phase 3 trial planned EC Expands Trodelvy + Keytruda Approval to First-Line Metastatic TNBC Across PD-L1 Status (Ref) European Commission’s expanded approval of Gilead’s Trodelvy (sacituzumab govitecan-hziy; Trop-2–directe

20/08/2026 US FDA Grants Fast Track Designation to Safusidenib for IDH1‑Mutant Glioma US FDA Grants Fast Track Designation to Safusidenib for IDH1‑Mutant Glioma (Ref) Nuvation Bio announced that the US FDA has granted Fast Track Designation to safusidenib (IDH1 inhibitor) for the treatment of IDH1‑mutant glioma. This designation enables expedited regulatory review and closer FDA engagement Phase 2 J201 trial showed a confirmed objective response rate of 51.9%, with durable re

August 2nd Week, 2026 Regulatory Events 🎯 The US FDA granted a Type C Statistical Methods Meeting to OS Therapies to review the 2.5yrs OS data from the Ph2b trial of daznelimgene lisbac (OST-HER2; HER2 targeted immunotherapy vaccine) in the prevention of recurrence in fully resected, pulmonary metastatic osteosarcoma (Ref) ❓ How is OST-HER2 positioned in the osteosarcoma developmental landscape? Special Designations ⭐ The US FDA granted a Fast Track Designation to Gran

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

18/08/2026 BH-30643 earns US FDA Fast Track designation for pretreated NSCLC FDA Endorses Registrational Path for Pelareorep in RAS‑Mutant MSS Colorectal Cancer PLN-101095 Secures US FDA Fast Track for ICI-Refractory Solid Tumors US FDA Grants Fast Track to ETX‑19477, a Novel PARG Inhibitor for BRCA‑Mutated Breast Cancer BH-30643 earns US FDA Fast Track designation for pretreated NSCLC (Ref) BlossomHill Therapeutics announced that its investigational drug BH-30643, a macrocyc

17/08/2026 Enhertu delivers first-ever PFS benefit in 1L HER2-mutant NSCLC AstraZeneca halts Phase 3 eVOLVE-Lung02 trial of volrustomig in mNSCLC ORPATHYS + TAGRISSO deliver survival benefit in MET-driven EGFRm NSCLC US FDA fast track designation granted for PIKTOR + paclitaxel in biomarker-selected advanced Endometrial Cancer UroGen submits NDA for UGN-103 in recurrent LG-IR-NMIBC Enhertu delivers first-ever PFS benefit in 1L HER2-mutant NSCLC (Ref) AstraZeneca and Daiichi S

13/08/2026 US FDA Grants Type C Meeting to Review OST-HER2 Survival Data in Osteosarcoma Celltrion announced that CT-P73, tissue factor–targeting ADC for recurrent/metastatic cervical cancer, received FDA fast track designation US FDA Grants Type C Meeting to Review OST-HER2 Survival Data in Osteosarcoma (Ref) OS Therapies announced that the US FDA has granted a Type C Statistical Methods meeting to review 2.5-year overall survival data from the Phase 2b OST-HER2 trial in pul

12/08/2026 NMPA approves ivonescimab + chemo for first‑line advanced squamous NSCLC Zipalertinib Combo Achieves PFS Milestone in EGFR Exon 20 NSCLC, FDA Filing Planned NMPA approves ivonescimab + chemo for first‑line advanced squamous NSCLC (Ref) China’s NMPA approved Akeso Bio & Summit Therapeutics' ivonescimab (PD-1 x VEGF) in combination with chemotherapy as first-line treatment for advanced squamous non-small cell lung cancer (sq-NSCLC) The approval was based on the signi

09/08/2026 US FDA Fast Track Designation for FAP‑targeted radionuclide conjugate GPN01530-2 US FDA Fast Track Designation for FAP‑targeted radionuclide conjugate GPN01530-2 (Ref) Grand Pharmaceutical Group Limited announced that its investigational radionuclide-drug conjugate GPN01530-2, targeting fibroblast activating protein (FAP), has received Fast Track Designation from the US FDA

07/08/2026 BioInvent Secures US FDA Fast Track Designation for BI‑1808 in Ovarian Cancer BioInvent Secures US FDA Fast Track Designation for BI‑1808 in Ovarian Cancer (Ref) BioInvent has received US FDA Fast Track designation for BI‑1808, its first‑in‑class anti‑TNFR2 antibody, in combination with pembrolizumab for the treatment of ovarian cancer Supporting Phase 2a study results: 24.0% confirmed overall response rate (ORR) 56.0% disease control rate (DCR) Median progression‑

Highlights from the CHMP July 2026 Meeting are out! Six oncology calls came out of the July CHMP meeting. Below are the key takeaways: 1) ADCs own the front line. 👉 Enhertu and Trodelvy both cleared first-line metastatic breast settings in combination. 2) Breast cancer is where the density is. 👉 All three positive opinions are in the Breast Cancer space 3) A met endpoint is not an EU approval. 👉 POTOMAC succeeded, and the FDA approved. CHMP still questioned the benefit-ris

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 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

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 recep

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