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

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 Bioth

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 approval

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 1)

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 appr

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) + daratumuma

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 re

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 granted a Pr

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 regenera

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 Designations ⭐ The

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) + durv

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 of A