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

April 1st Week, 2026 Regulatory Events 🎯 The EC approved Merck & Co./ MSD 's pembrolizumab (anti-PD-1) + paclitaxel ± bevacizumab for the Tx of platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma in adults with PD-L1 CPS ≥1, and who have received one or two prior systemic Tx regimens (Ref 1) ❓ How is the regimen positioned in EU market landscape? Special Designations ⭐ The US FDA granted the breakthrough therapy designation to Fore

March 4th Week, 2026 Regulatory Events 🎯 The US FDA granted approval to Corcept Therapeutics Incorporated's relacorilant (selective glucocorticoid receptor antagonist) + nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab. (Ref 1) ❓ What are the clinical outcomes that support this approv

March 3rd Week, 2026 Regulatory Events 🎯 The US FDA approved Bristol Myers Squibb 's nivolumab (anti-PD-1) + doxorubicin + vinblastine + dacarbazine for the treatment of adult and pediatric patients 12 years and older with previously untreated, Stage III/IV cHL. Additionally, the EC approved nivolumab + brentuximab vedotin for the treatment of children 5 years of age and older, adolescents, and adults up to 30 years of age with R/R cHL after one prior line of therapy. (Ref

March 2nd Week, 2026 Regulatory Events 🎯 The EC has approved an indication extension for Johnson & Johnson Innovative Medicine 's AKEEGA® (niraparib and abiraterone acetate dual action tablet) with prednisone or prednisolone in combination with androgen deprivation therapy, for the treatment of patients with metastatic hormone-sensitive prostate cancer and BRCA1/2 mutations (germline and/or somatic). (Ref 1) ❓ How do the outcomes of this regimen compare against the other ap

March 1st Week, 2026 Regulatory Events 🎯 The European Commission approved Incyte ’s retifanlimab (anti-PD-1) + carboplatin + paclitaxel for the first-line treatment of adult patients with metastatic or with inoperable locally recurrent squamous cell carcinoma of the anal canal. (Ref 1) ❓ How do the outcomes of this regimen compare against the current SOC? 🎯 The US FDA approved Johnson & Johnson Innovative Medicine ’s teclistamab (BCMA-directed CD3 T-cell engager) + daratu

February 2nd Week, 2026 Regulatory Events 🎯 The US FDA approved Merck & Co/ MSD 's Keytruda (pembrolizumab; anti-PD-1) as well as Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph subcutaneous product) in combination with paclitaxel, with or without bevacizumab, for adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS≥1), and who have received one or two prior systemic treatment

February 1st Week, 2026 Regulatory Events 🎯 The US FDA approved an update to Gilead Sciences ' axicabtagene ciloleucel (anti-CD19 CAR-T) prescribing information removing the previous “Limitations of Use” in patients with relapsed/refractory primary central nervous system lymphoma (Ref 1) ❓ How would this decision alter Yescarta’s positioning in the market landscape? 🎯 AstraZeneca and Daiichi Sankyo US ’ sBLA for datopotamab deruxtecan (TROP2 ADC) was accepted and grante

January 2nd Week, 2026 Regulatory Events 🎯 Summit Therapeutics, Inc. has submitted a biologics license application to the US FDA seeking approval for Akeso Biopharma & Summit's ivonescimab (PD-1 x VEGF BsAb) + chemotherapy in second-line or later treatment of patients with EGFR-mutated locally advanced or metastatic non-squamous NSCLC. (Ref 1) ❓ What are the launch timeline estimates for the regimen in this indication? Special Designations ⭐ The US FDA granted the rege

January 1st Week, 2026 Clinical Events 🔬 Per primary analysis from the Phase 3 HERIZON-GEA-01 trial, Jazz Pharmaceuticals , BeOne Medicines and Zymeworks Inc. 's zanidatamab (bispecific HER2-directed antibody) + chemo ± BeOne Medicines ' tislelizumab (anti-PD-1) met the PFS endpoint as a first-line treatment of HER2+, locally advanced or metastatic gastroesophageal adenocarcinoma. (Ref 1) ❓ What are the current survival benchmarks for this indication? Special Designatio

December 4th Week, 2025 Regulatory Events 🎯 The US FDA granted accelerated approval to Roche 's Lunsumio VELO (mosunetuzumab; CD20 x CD3 BsAb), as a subcutaneous formulation, for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. (Ref 1) ❓ What are the key pros and cons of this subcutaneous therapy? Clinical Events 🔬 The Phase 3 LATIFY trial of AstraZeneca 's ceralasertib (ATR kinase inhibitor) +

December 2nd Week, 2025 Regulatory Events 🎯 The US FDA granted approval to Johnson & Johnson Innovative Medicine 's sNDA for niraparib and abiraterone acetate dual-action tablet (PARB inhibition and novel hormonal therapy) + prednisone for the treatment of patients with BRCA2-mutated metastatic castration-sensitive prostate cancer. (Ref 1) ❓ How is this approval expected to impact the treatment algorithm of the indication? Clinical Events 🔬 The Phase 3 STAR-221 trial o

December 1st Week, 2025 Regulatory Events 🎯 The US FDA granted approval to Eli Lilly and Company 's pirtobrutinib (BTK inhibitor) for the treatment of adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor. (Ref 1) ❓ How is this approval expected to impact the treatment algorithm of the indication? 🎯 The US FDA granted approval to Bristol Myers Squibb 's lisocab