08/09/2026 Imfinzi + Imdelltra demonstrated significant benefit in 1st‑line ES‑SCLC maintenance In registrational Phase 2 QUINTESSENTIAL trial, GPRC5D CAR T therapy (arlo‑cel) achieved significant ORR improvement in heavily pretreated multiple myeloma INBRX‑106 + pembrolizumab elicited strong ORR signal in Phase 2 part of Ph2/3 HexAgon-HN trial, driving expansion and FDA‑aligned path to Phase 3 confirmatory trial in HNSCC Imfinzi + Imdelltra demonstrated significant benefit i

03/09/2026 Phase 3 CERVINO interim analysis shows etentamig significantly improves ORR and PFS in RRMM, with IDMC recommending study unblinding Phase 3 CERVINO interim analysis shows etentamig significantly improves ORR and PFS in RRMM, with IDMC recommending study unblinding (Ref) AbbVie reported positive topline results from the Phase 3 CERVINO trial, demonstrating that etentamig (BCMA x CD3 bispecific T-cell engager) significantly improved response rates and progression-fr

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

23/07/2026 Phase 3 MonumenTAL-6 study shows PFS benefit for TECVAYLI + TALVEY combo in Multiple Myeloma Epcoritamab Phase 3 DLBCL trial failed to meet OS endpoint Phase 3 MonumenTAL-6 study shows PFS benefit for TECVAYLI + TALVEY combo in Multiple Myeloma (Ref) Johnson & Johnson announced positive topline results from the Phase 3 MonumenTAL-6 trial of TECVAYLI and TALVEY combinations in relapsed/refractory multiple myeloma patients. MonumenTAL-6 trial evaluated TECVAYLI® (tec

13/07/2026 FDA accepts BMS’s NDA for mezigdomide in relapsed/refractory Multiple Myeloma GSK’s dostarlimab (aPD-1) delivers sustained complete responses in dMMR/MSI-H rectal cancer FDA accepts BMS’s NDA for mezigdomide in relapsed/refractory Multiple Myeloma (Ref) The US FDA has accepted Bristol Myers Squibb’s New Drug Application (NDA) for mezigdomide in combination with carfilzomib and dexamethasone (MeziKd) for relapsed/refractory multiple myeloma (RRMM) A Prescription Dru

17/06/2026 Avenacy Launches Bortezomib for Injection in the U.S., Marking Its 28th Product Since Inception Avenacy Launches Bortezomib for Injection in the U.S., Marking Its 28th Product Since Inception (Ref) Avenacy has officially launched Bortezomib for Injection in the US, a generic equivalent of VELCADE® indicated for adults with multiple myeloma and mantle cell lymphoma The product is available as a 3.5 mg single-dose vial and features Avenacy's differentiated packaging

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

15/04/2026 FDA Grants Orphan Drug Status to Immutep’s Eftilagimod Alfa in Soft Tissue Sarcoma FDA Grants Fast Track to Opna Bio’s OPN-6602 for Relapsed/Refractory Multiple Myeloma FDA Grants Orphan Drug Status to Immutep’s Eftilagimod Alfa in Soft Tissue Sarcoma (Ref) Immutep’s lead candidate, eftilagimod alfa (efti), has received Orphan Drug Designation from the U.S. FDA for soft tissue sarcoma (STS), a rare cancer with high unmet need Supporting clinical data: Based on resu

31/03/2026 Caribou Biosciences' CB-011 received the FDA RMAT designation for multiple myeloma Caribou Biosciences' CB-011 received the FDA RMAT designation for multiple myeloma (Ref) The US FDA granted the Regenerative Medicine Advanced Therapy (RMAT) designation to Caribou Biosciences' CB-011 (allogeneic anti-BCMA CAR-T) for relapsed or refractory multiple myeloma (r/r MM). The cell therapy is being evaluated in the open-label, multicenter Phase 1 CaMMouflage clinical trial

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)

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

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

27/01/2026 Johnson & Johnson's DARZALEX FASPRO regimen has been approved in the US for multiple myeloma Imviva Biotech's CTD402 CAR-T received the FDA orphan drug designation for T-ALL/LBL Nanjing Leads Biolabs' LBL-034 received the FDA fast track designation for multiple myeloma Johnson & Johnson's DARZALEX FASPRO regimen has been approved in the US for multiple myeloma (Ref) The US FDA granted approval to Johnson & Johnson's DARZALEX FASPRO (daratumumab and hyaluronidase-fi

26/01/2026 Cogent Biosciences' bezuclastinib + sunitinib received the FDA Breakthrough Therapy Designation for GIST Innovent Biologics' IBI3003 received the FDA Fast Track Designation for multiple myeloma Cogent Biosciences' bezuclastinib + sunitinib received the FDA Breakthrough Therapy Designation for GIST (Ref) The US FDA granted the Breakthrough Therapy Designation to Cogent Biosciences' bezuclastinib (tyrosine kinase inhibitor) in combination with sunitinib for patients

15/12/2025 Daiichi Sankyo and AstraZeneca's trastuzumab deruxtecan + pertuzumab has been approved for first-line HER2+ve breast cancer FibroGen's roxadustat received the FDA Orphan Drug Designation for myelodysplastic syndromes Eli Lilly's TECVAYLI plus DARZALEX FASPRO combo has been selected for the FDA's CNPV Pilot program Daiichi Sankyo and AstraZeneca's trastuzumab deruxtecan + pertuzumab has been approved for first-line HER2+ve breast cancer (Ref) The US FDA granted appr

06/11/2025 Johnson & Johnson's Darzalex Faspro has been approved by the FDA for HR-SMM (Ref) The US FDA approved Johnson & Johnson's Darzalex Faspro® (daratumumab and hyaluronidase-fihj) as a single agent treatment for adult patients with high-risk smoldering multiple myeloma (HR-SMM). The approval is based on results from the Ph3 AQUILA/NCT03301220 trial, which evaluated the efficacy and safety of Darzalex Faspro vs active monitoring (or “Watch and Wait”) in patients with HR

September 4th Week, 2025 Regulatory Events 🎯 The US FDA approved Eli Lilly and Company's imlunestrant (oral estrogen receptor antagonist) for the Tx of adults with ER+, HER2–, ESR1-mutated advanced or metastatic breast cancer whose disease progressed after at least one line of endocrine therapy. (Ref 1) ❓ How is this approval expected to impact the Tx paradigm? 🎯 Nuvalent, Inc., completed its NDA submission to the US FDA for zidesamtinib (ROS1-selective macrocyclic tyrosine

23/09/2025 Kelun Biotech's NDA for A400/EP0031 in RET +ve NSCLC was accepted by China's NMPA (Ref) China's NMPA has accepted Sichuan Kelun-Biotech's NDA for A400/EP0031 (RET kinase inhibitor) for the treatment of adult patients with RET-fusion positive locally advanced, or metastatic NSCLC The acceptance for review was based on the positive results from the two pivotal Ph2 cohorts of the KL400-I/II-01 study for both 1L and 2L+ advanced RET-fusion positive NSCLC To note, in Ma

30/07/2025 Phase 3 COSTAR Lung trial of dostarlimab + docetaxel ± cobolimab failed to meet the OS endpoint in previously treated NSCLC (Ref) GSK's Phase 3 COSTAR Lung/NCT04655976 trial of dostarlimab (anti-PD-1) + docetaxel ± cobolimab (anti-TIM-3) combinations did not meet the primary endpoint of improving OS vs docetaxel alone in advanced NSCLC that has progressed on prior PD-(L)1 therapy and chemotherapy. All regimens were well tolerated and toxicities were consistent with