September 3rd Week, 2026 Regulatory Events 🎯 AstraZeneca’s sBLA for perioperative durvalumab (Imfinzi; anti-PD-L1) + Astellas Pharma and Pfizer’s neoadjuvant enfortumab vedotin (Padcev; Nectin-4 ADC) was accepted and granted Priority Review by the US FDA for the Tx of MIBC patients who are ineligible/have declined cisplatin-based chemotherapy (Ref1) ❓ What are the current efficacy benchmarks for perioperative MIBC? 🎯 The US FDA approved Merck&Co/MSD's belzutifan (Welir

September 2nd Week, 2026 Regulatory Events 🎯 The US FDA granted Accelerated Approval to Bayer’s sevabertinib (HYRNUO; mutant HER2 TKI) for the 1L Tx of HER2-mutant nsq-NSCLC with HER2/ERBB2 tyrosine kinase domain activating mutations (Ref1) ❓ How is sevabertinib positioned in NSCLC Tx landscape? 🎯 The US FDA extended the review period for Exelixis' zanzalintinib (multi-TKI) + Roche's atezolizumab (Tecentriq; anti-PD-L1) NDA for pretreated MSS CRC by 3 months, resulting i

September 1st Week, 2026 Regulatory Events 🎯 The US FDA granted an accelerated approval to AstraZeneca's camizestrant (Etcamah; SERD and complete ER antagonist) + a CDK4/6 inhibitor for the 1L Tx of HR+/HER2- ESR1-mutated LA/M breast cancer (Ref1) ❓ What is the addressable market size for Etcamah in the US? 🎯 AstraZeneca and Daiichi Sankyo' trastuzumab deruxtecan (Enhertu; HER2 ADC) + pertuzumab (anti-HER2) has secured EU approval as 1L Tx for HER2+ unresectable or met

August 4th Week, 2026 Regulatory Events 🎯 The US FDA has approved Jazz Pharmaceuticals, BeOne Medicines and Zymeworks Inc.' zanidatamab-hrii (Ziihera; biparatopic HER2 BsAb) + fluoropyrimidine- and platinum-containing chemo ± BeOne's tislelizumab-jsgr (Tevimbra; anti-PD-1) for the first-line Tx of adults with HER2+ advanced gastroesophageal adenocarcinoma (GEA) (Ref1) ❓ How is the approval expected to impact the GEA Tx paradigm? 🎯 The EC has approved Gilead Sciences’s

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

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

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

July 2nd Week, 2026 Special Designation ⭐ PRG S&Tech Inc.’s Trineumin (small-molecule modulator of the abnormal TβR1-RKIP interaction (caused by NF2 gene mutation)) has been granted the Rare Pediatric Disease Designation (RPDD) by the US FDA for the Tx of Neurofibromatosis Type 2 (NF2) (Ref) ❓ What is the addressable market for NF2 in the US? ⭐ CSPC Pharmaceutical Group's SYS6043 (B7-H3 ADC) received the Breakthrough Therapy Designation from China’s NMPA for the Tx of plati

June 4th Week, 2026 Regulatory Updates 🎯 Pfizer's palbociclib (Ibrance; CDK4/6 inhibitor) has been approved in the US for use with trastuzumab (anti-HER2) ± pertuzumab (anti-HER2), and endocrine therapy as 1L maintenance Tx for HR+, HER2+ LA/M breast cancer following induction therapy (Ref 1) ❓ How is Ibrance positioned in the BC market landscape? 🎯 The US FDA approved Gilead Sciences’ sacituzumab govitecan-hziy (Trodelvy; TROP2 ADC) for the 1L Tx of unresectable LA/M TNB

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

May 3rd Week, 2026 Regulatory Events 🎯 Shanghai Junshi Biosciences Co Ltd’s NDA for toripalimab (anti-PD-1) + RemeGen Biosciences’ disitamab vedotin (HER2 ADC) for patients with HER2-expressing LA/M urothelial carcinoma was approved by the NMPA. (Ref 1) ❓ What are the clinical outcomes that support this approval? Special Designations ⭐ The US FDA granted the Priority Review status to Bayer’s sevabertinib (HER2 TKI) for the first-line treatment of adult patients with LA/M

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

May 1st Week, 2026 Regulatory Events 🎯 Pierre Fabre Laboratories aligned with the US FDA for resubmission of the BLA for tabelecleucel (allogeneic T‑cell therapy) for R/R EBV+ post‑transplant lymphoproliferative disease who have received at least one prior therapy including an anti-CD20 containing regimen (Ref 1) ❓ How is tabelecleucel positioned in the current Lymphoma market landscape? 🎯 Nuvation Bio’s supplemental NDA with updated data for taletrectinib (IBTROZI®; TK

April 5th Week, 2026 Regulatory Events 🎯 The EC granted approval to Henlius’ pertuzumab biosimilar (anti-HER2; POHERDY) for HER2+ early and metastatic breast cancer (Ref 1) ❓ Which are the other key pertuzumab biosimilars in the EU market? 🎯 The US FDA accepted the sBLA and granted priority review to Jazz Pharmaceuticals, BeOne Medicines and Zymeworks Inc.' zanidatamab (HER2-directed BsAb) + chemotherapy ± BeOne Medicines' tislelizumab (anti-PD-1) for the first-line trea

April 4th Week, 2026 Regulatory Events 🎯 The EC granted conditional marketing authorization to Ipsen’s tovorafenib (Ojemda; type II RAF kinase inhibitor) monotherapy for the treatment of pediatric low-grade-glioma harboring a BRAF fusion or rearrangement, or BRAF V600 mutation, who have progressed after one or more prior systemic therapies (Ref 1) ❓ What is the addressable market for pLGG in EU? 🎯 The US FDA accepted a supplemental BLA for Pfizer and Astellas Pharma’s

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

April 2nd Week, 2026 Regulatory Events 🎯 CARsgen Therapeutics Therapeutics’ satri-cel (Claudin18.2 targeted autologous CAR-T) is anticipated to be available in China by H1’26 for the treatment of patients with advanced gastric and gastroesophageal cancers (Ref 1) ❓ What is the current SOC for GEJ/GC in China? 🎯 The NDA for Duality Biologics and BioNTech SE's trastuzumab pamirtecan (T-Pam; HER2 ADC) has been accepted by China’s National Medical Products Administration f