24/03/2026 The Ph3 SENTRY trial of Karyopharm's selinexor + ruxolitinib met SVR35 but not Abs-TSS endpoint in frontline myelofibrosis ReCerise's RCT1213 received the FDA ODD for hepatocellular carcinoma The Ph3 SENTRY trial of Karyopharm's selinexor + ruxolitinib met SVR35 but not Abs-TSS endpoint in frontline myelofibrosis (Ref) Karyopharm Therapeutics reported topline results from its Phase 3 SENTRY trial of selinexor 60 mg + ruxolitinib in frontline myelofibrosis. The tria

19/02/2026 Enhertu's type II variation application has been validated by the EMA for HER2 +ve early Breast Cancer Pilatus Biosciences' PLT012 received the FDA Fast Track designation for HCC Genentech's NDA for giredestrant + everolimus has been accepted by the US FDA for certain patients with breast cancer Enhertu's type II variation application has been validated by the EMA for HER2 +ve early Breast Cancer (Ref) The EMA has validated the type II variation marketing authoriz

10/02/2026 Abbisko Therapeutics' irpagratinib received the FDA fast track designation for certain patients with HCC Merck's Keytruda/Keytruda Qlex regimen received FDA approval for PD-L1 positive Ovarian Cancer AstraZeneca & Daiichi's Phase 3 TROPION-Lung12 trial in stage I NSCLC has been discontinued Abbisko Therapeutics' irpagratinib received the FDA fast track designation for certain patients with HCC (Ref) The US FDA granted the fast track designation to Abbisko Therapeut

04/12/2025 BMS' Breyanzi received FDA approval for R/R MZL J & D Pharmaceuticals' investigational therapy received the FDA orphan drug designation for HCC BMS' Breyanzi received FDA approval for R/R MZL (Ref) The US FDA granted approval to Bristol Myers Squibb's lisocabtagene maraleucel (Breyanzi; CD19-directed CAR-T cell therapy) for the treatment of adult patients with R/R marginal zone lymphoma who have received at least two prior lines of systemic therapy. The approval

29/10/2025 Merck's perioperative Keytruda regimen received approval from the EC for LA SCCHN with PD-L1 CPS ≥1 (Ref) The European Commission (EC) has approved Merck & Co./MSD's pembrolizumab (anti-PD-1) single agent as a neoadjuvant Tx followed by adjuvant pembrolizumab + RT with or without cisplatin after surgery, and then as a single agent for adults with resectable locally advanced SCCHN with PD-L1 CPS ≥1. The approval follows a positive CHMP opinion, and is based on resul

August 4th Week, 2025 Regulatory Events 🎯 Health Canada issued a NOC/c for Iovance Biotherapeutics, Inc.'s lifileucel (autologous TIL therapy) for adult patients with unresectable or metastatic melanoma that has progressed on or after at least one prior systemic therapy including an anti-PD-1, and if BRAF V600 mutant, BRAF inhibitor ± MEK inhibitor, and who have no satisfactory alternative treatment options. (Ref 1) ❓ How is this approval going to impact the Melanoma treat

Health Canada approved Bristol Myers Squibb's nivolumab (Opdivo; anti-PD-1) + ipilimumab (Yervoy; anti-CTLA-4) for the first-line treatment of adult patients with: Unresectable or metastatic MSI-H/dMMR colorectal cancer, and Unresectable or advanced hepatocellular carcinoma

13/08/2025 Merck's perioperative Keytruda regimen received approval in Canada for resectable HNSCC with PD-L1 CPS ≥1 (Ref) Health Canada granted approval to Merck & Co./MSD's pembrolizumab (anti-PD-1) mono as a neoadjuvant treatment, then continued as adjuvant treatment in combination with RT +/- cisplatin and then as monotherapy for adult patients with resectable locally advanced HNSCC with PD-L1 CPS ≥1. The approval is based on results from the Phase 3 KEYNOTE-689 trial in

04/08/2025 Alphamab's IND application for JSKN022 was accepted by China's CDE (Ref) Alphamab Oncology's IND application for JSKN022 (PD-L1 x integrin αvβ6 bispecific antibody-drug conjugate) has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The company plans to initiate a first-in-human trial of JSKN022 for the treatment of advanced malignant solid tumors The Ph1 trial will evaluate the safety, tolerability, PK/P

July 2nd Week, 2025 Regulatory Updates 🎯 The EC approved BeOne Medicines' tislelizumab (anti-PD-1) + gemcitabine + cisplatin for the first-line Tx of metastatic or recurrent nasopharyngeal carcinoma (NPC), not amenable to curative surgery or radiotherapy. (Ref 1) ❓ What are the other key Asia-specific trials emerging in this indication? 🎯 The UK’s MHRA granted marketing authorization to ImmunityBio, Inc.'s nogapendekin alfa inbakicept-pmln (lymphocyte-stimulating agent

07/07/2025 SIR-Spheres® Y-90 Resin Microspheres received FDA approval for HCC (Ref) The US FDA approved Sirtex Medical's SIR-Spheres Y-90 resin microspheres for the Tx of unresectable HCC The approval is based on the results from the prospective, multi-center, open-label DOORwaY90 trial DOORwaY90 met its prespecified primary endpoints with a ORR of 98.5%; the median DoR exceeded 300 days Matt Schmidt, CEO, Sirtex: "The expanded indication makes SIR-Spheres® the only Y-90 tr