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

23/03/2026 AstraZeneca & Daiichi Sankyo's ENHERTU received approval in Japan for HER2+ solid cancers AstraZeneca & Daiichi Sankyo's ENHERTU received approval in Japan for HER2+ solid cancers (Ref) Japan’s Ministry of Health, Labour and Welfare (MHLW) granted approval to AstraZeneca & Daiichi Sankyo's ENHERTU® (trastuzumab deruxtecan) for the treatment of adult patients with HER2+, advanced or recurrent solid cancers refractory or intolerant to standard treatments. The approva

21/03/2026 Dizal's Phase 3 WU-KONG28 trial of ZEGFROVY met its PFS endpoint as a first-line treatment of EGFRexon20ins NSCLC Dizal's Phase 3 WU-KONG28 trial of ZEGFROVY met its PFS endpoint as a first-line treatment of EGFRexon20ins NSCLC (Ref) The multinational Phase 3 WU-KONG28 trial evaluating Dizal's ZEGFROVY® (sunvozertinib) monotherapy as first-line treatment in NSCLC with EGFR exon20ins met its primary endpoint of PFS. The WU-KONG28 study evaluated ZEGFROVY versus plat

20/03/2026 BMS received approvals from US FDA and EC for Opdivo-based treatment combinations for classical Hodgkin Lymphoma BMS received approvals from US FDA and EC for Opdivo-based treatment combinations for classical Hodgkin Lymphoma (Ref) 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 or IV cHL. Additionally,

19/03/2026 Remix Therapeutics' REM-422 received the FDA fast track designation for adenoid cystic carcinoma Remix Therapeutics' REM-422 received the FDA fast track designation for adenoid cystic carcinoma (Ref) The US FDA granted the fast track designation to Remix Therapeutics' REM-422 (MYB mRNA degrader) for the treatment of patients with recurrent, metastatic or unresectable adenoid cystic carcinoma (ACC) whose tumors express MYB transcripts containing a poison exon. REM-4

18/03/2026 Idience's venadaparib received the FDA fast track designation for gastric cancer FluoGuide's FG001 imaging agent received the FDA fast track designation for glioma Idience's venadaparib received the FDA fast track designation for gastric cancer (Ref) The US FDA granted the fast track designation to Idience's venadaparib (PARP inhibitor) for the treatment of gastric cancer. Lee Won-sik, CEO, Idience: “This Fast Track designation is highly meaningful in that the FDA

17/03/2026 CRISM Therapeutics' irinotecan received the FDA ODD for malignant glioma Voro Therapeutics and Daiichi Sankyo sign a research collaboration for Next-Generation Tumor-Activated ADCs Myriad Genetics' MyChoice CDx test received FDA approval as the companion diagnostic for Zejula CRISM Therapeutics' irinotecan received the FDA ODD for malignant glioma (Ref) The US FDA granted the Orphan Drug Designation to CRISM Therapeutics Corporation's irinotecan for the treatment o

16/03/2026 AstraZeneca’s perioperative durvalumab regimen received EC approval for early gastric and gastroesophageal cancers Telix resubmitted NDA to the US FDA for TLX101-Px brain cancer imaging candidate AstraZeneca’s perioperative durvalumab regimen received EC approval for early gastric and gastroesophageal cancers (Ref) The EC granted approval to AstraZeneca’s durvalumab (anti-PD-L1) + standard-of-care FLOT chemotherapy for the treatment of adult patients with resectabl

13/03/2026 Immutep's Phase 3 TACTI-004 trial of eftilagimod alfa regimen in 1L NSCLC NSCLC has been discontinued Immutep's Phase 3 TACTI-004 trial of eftilagimod alfa regimen in 1L NSCLC NSCLC has been discontinued (Ref) Based on the Independent Data Monitoring Committee (IDMC) recommendation, Immutep's Phase 3 TACTI-004 trial of eftilagimod alfa (LAG-3 MHC Class II agonist) + pembrolizumab + chemo regimen as a first-line treatment of NSCLC has been discontinued. Following a

12/03/2026 Aminex Therapeutics' AMXT 1501 received the FDA ODD for Glioma Aminex Therapeutics' AMXT 1501 received the FDA ODD for Glioma (Ref) The US FDA granted the orphan drug designation to Aminex Therapeutics' AMXT 1501 (polyamine transport inhibitor) + difluoromethylornithine for the treatment of malignant glioma, including diffuse intrinsic pontine glioma (DIPG). The Beat Childhood Cancer Research Consortium at Penn State College of Medicine, in partnership with Aminex,

09/03/2026 Johnson & Johnson's AKEEGA regimen received EC approval for the treatment of BRCA1/2-mutated mHSPC BMS announced positive Ph3 data of oral mezigdomide regimen in R/R Multiple Myeloma AstraZeneca and Daiichi Sankyo’s Enhertu received priority review status for HER2-positive early breast cancer Roche announced failure of the Phase 3 persevERA Breast Cancer trial Johnson & Johnson's AKEEGA regimen received EC approval for the treatment of BRCA1/2-mutated mHSPC (Ref)

26/02/2026 Boehringer Ingelheim's zongertinib received accelerated approval for HER2m NSCLC Izalontamab brengitecan elicited significant PFS and OS benefit in TNBC Boehringer Ingelheim's zongertinib received accelerated approval for HER2m NSCLC (Ref) The US FDA granted accelerated approval to Boehringer Ingelheim's zongertinib (kinase inhibitor) for an expanded indication for adults with unresectable or metastatic non-squamous NSCLC whose tumors have HER2 TKD activating mutat

24/02/2026 Pfizer's encorafenib + cetuximab + chemo received FDA traditional approval for CRC Siren Biotechnology's SRN-101 received the FDA fast track designation for HGG Aktis Oncology's AKY-1189 received the FDA fast track designation for mUC Onconic Therapeutics' nesuparib received the FDA orphan drug designation for SCLC Pfizer's encorafenib + cetuximab + chemo received FDA traditional approval for CRC (Ref) The US FDA granted traditional approval to Pfizer's encorafenib

23/02/2026 Artios Pharma's ART6043 + olaparib received the FDA fast track designation for breast cancer RYBREVANT SC received EC approval for Q3W and Q4W dosing for EGFR-mutated NSCLC Artios Pharma's ART6043 + olaparib received the FDA fast track designation for breast cancer (Ref) The US FDA granted the Fast Track designation to Artios Pharma's ART6043 (DNA polymerase theta (Polθ) inhibitor) + olaparib (PARP inhibitor) for the treatment of adult patients with germline BRCA-m

Welcome to the January edition of our CGT Watch newsletter! Stay informed on the latest advancements in the CGT space—subscribe now to receive insightful updates straight to your inbox. Dear Readers, We’re excited to bring you Jan edition of CGT watch highlighting updates on novel targets, innovative approaches, first-of-its-kind combinations, and key developments. Since we’re keen to keep things concise and focused, this issue will exclusively cover cell therapies. 🎯 Regula

18/02/2026 ImmunityBio's ANKTIVA® + BCG received conditional marketing authorization in Europe for BCG-unresponsive NMIBC CIS Johnson & Johnson's subcutaneous amivantamab received the FDA Breakthrough Therapy Designation for HPV-unrelated R/M SCCHN ImmunityBio's ANKTIVA® + BCG received conditional marketing authorization in Europe for BCG-unresponsive NMIBC CIS (Ref) The EC granted conditional marketing authorization to ImmunityBio's ANKTIVA® (nogapendekin alfa inbakicept) +

17/02/2026 Deciphera Pharmaceuticals' NDA for tirabrutinib has been accepted by the US FDA for R/R PCNSL J&J's RYBREVANT FASPRO™ received FDA approval for once a month dosing schedule for EGFRm NSCLC BMS' NDA for iberdomide + standard treatment has been accepted by the US FDA for R/R MM Deciphera Pharmaceuticals' NDA for tirabrutinib has been accepted by the US FDA for R/R PCNSL (Ref) The US FDA has accepted for filing the NDA under the accelerated approval pathway for Deciph

16/02/2026 Phase 3 LIBRETTO-432 trial of adjuvant selpercatinib met the EFS endpoint in RET fusion positive NSCLC Phase 3 LIBRETTO-432 trial of adjuvant selpercatinib met the EFS endpoint in RET fusion positive NSCLC (Ref) Eli Lilly and Company announced positive topline results from the Phase 3 LIBRETTO-432 clinical trial of selpercatinib (Retevmo; RET kinase inhibitor) as an adjuvant therapy versus placebo in patients with early-stage (II-IIIA) RET fusion-positive NSCLC. Th

13/02/2026 HanchorBio's HCB101 received the FDA orphan drug designation for gastric cancer HanchorBio's HCB101 received the FDA orphan drug designation for gastric cancer (Ref) The US FDA granted the Orphan Drug Designation to HanchorBio's HCB101 (CD47–SIRPα pathway inhibitor) for the treatment of gastric cancer. The designation covers gastric cancer broadly, including advanced gastric adenocarcinoma in both HER2-positive and HER2-negative subtypes HCB101 is currently being e

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