27/05/2026 FDA grants Fast Track to Solu’s STX‑0712 for relapsed/refractory CMML, advancing CyTAC™ platform into Phase 1 hematology trials FDA grants Fast Track to Solu’s STX‑0712 for relapsed/refractory CMML, advancing CyTAC™ platform into Phase 1 hematology trials (Ref) Solu Therapeutics’ investigational therapy STX-0712 has received Fast Track designation for relapsed/refractory chronic myelomonocytic leukemia (CMML) Ongoing Trials - A Phase 1, open-label, multicenter tria

19/05/2026 Cullinan’s CLN‑049 earns FDA Orphan Drug Designation in relapsed/refractory AML FL118 Receives Dual FDA Designations for Osteosarcoma, Advancing Rare Pediatric Cancer Treatment Cullinan’s CLN‑049 earns FDA Orphan Drug Designation in relapsed/refractory AML (Ref) LN-049, a novel FLT3 x CD3 T cell engager, has received Orphan Drug Designation for relapsed/refractory acute myeloid leukemia (AML) CLN-049 is in Phase 1 trials, including multiple ascending dose studies i

Highlights from the CHMP Apr 2026 Meeting are out! New Generics 💊 Viatris' palbociclib (Palbociclib Viatris; CDK4/6 inhibitor) for the treatment of HR+ HER2- locally advanced or metastatic breast cancer either in in combination with an aromatase inhibitor, or in combination with fulvestrant in women who have received prior endocrine therapy Indication Expansions 💊 Otsuka Pharmaceutical Companies (U.S.)'s fixed‑dose oral combination of decitabine‑cedazuridine (Inaqovi; hypom

13/01/2026 Ipsen's IPN60340 received the FDA Breakthrough Therapy Designation for AML Ipsen's IPN60340 received the FDA Breakthrough Therapy Designation for AML (Ref) The US FDA granted the Breakthrough Therapy Designation to Ipsen's IPN60340 (anti-BTN3A) in combination with venetoclax and azacitidine in first line unfit acute myeloid leukemia. Christelle Huguet, PhD, EVP and Head of R&D, Ipsen: “This Breakthrough Therapy Designation recognizes both the urgent need for new tr

09/12/2025 Senti Biosciences' SENTI-202 received the FDA's RMAT designation for hematologic malignancies Zydus and Formycon enter into an exclusive partnership for the Keytruda biosimilar, FYB206 Senti Biosciences' SENTI-202 received the FDA's RMAT designation for hematologic malignancies (Ref) The US FDA granted the Regenerative Medicine Advanced Therapy (RMAT) designation to Senti Biosciences' SENTI-202 (logic gated off-the-shelf CAR-NK cell therapy) for the treatment of re

01/12/2025 Cullinan Therapeutics' CLN-049 received the FDA fast track designation for R/R Acute Myeloid Leukemia Astellas Pharma and Pfizer's Type II variation application for perioperative enfortumab vedotin + pembro has been valiated by the EMA Cullinan Therapeutics' CLN-049 received the FDA fast track designation for R/R Acute Myeloid Leukemia (Ref) The US FDA granted the fast track designation to Cullinan Therapeutics' CLN-049 (FLT3 x CD3 bispecific T cell engager) for th

November 2nd Week, 2025 Regulatory Events 🎯 The US FDA granted full approval to Kura Oncology, Inc. and Kyowa Kirin Co., Ltd.'s ziftomenib (menin inhibitor) for adult patients with R/R AML with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. (Ref 1) ❓ How is this approval expected to impact the Tx algorithm of AML? Clinical Events 🔬 In the Phase 3 PEAK trial, Cogent Biosciences' bezuclastinib (KIT inhibitor) + sunitinib met the primary en

13/11/2025 Kura Oncology and Kyowa Kirin's ziftomenib received FDA approval for certain R/R AML pts (Ref) The US FDA granted full approval to Kura Oncology and Kyowa Kirin's ziftomenib (KOMZIFTI™; menin inhibitor) for adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. Troy Wilson, President and CEO, Kura Oncology: “KOMZIFTI combines compelling efficacy, a favor

November 1st Week, 2025 Regulatory Events 🎯 The US FDA approved Johnson & Johnson's Darzalex Faspro (daratumumab, an anti-CD38, and hyaluronidase) as a single agent treatment for adult patients with high-risk smoldering multiple myeloma (HR-SMM). (Ref 1) ❓ How is this approval expected to impact the treatment algorithm of this indication? Clinical Events 🔬 In the registrational cohort of the Phase 2 IOV-LUN-202/NCT04614103 trial, Iovance Biotherapeutics, Inc.’s lifileucel m

05/11/2025 Leukogene Therapeutics' LTI-214 received the FDA orphan drug designation for AML (Ref) The US FDA granted the orphan drug designation to Leukogene Therapeutics' LTI-214 (M2T-CD33; myeloid-targeted immunotherapy) for the treatment of Acute Myeloid Leukemia (AML). Sandeep Gupta, CEO, Leukogene: “We are honored that the FDA has recognized the therapeutic promise of LTI-214 by granting Orphan Drug Designation. AML remains one of the most challenging hematologic cancers

06/10/2025 Orca Bio's BLA for Orca-T accepted for Priority Review to treat Hematological Malignancies (Ref) The US FDA accepted Orca Bio's BLA seeking approval for Orca-T (allogeneic T-cell immunotherapy) as a treatment for hematological malignancies including acute myeloid leukemia, acute lymphoblastic leukemia and myelodysplastic syndromes. Priority Review status has been granted with a PDUFA target action date of April 6, 2026 The BLA submission was based on positive resul

September 3rd Week, 2025 Regulatory Events 🎯 The US FDA approved Merck & Co/MSD’s Keytruda Qlex (subcutaneous injection of pembrolizumab and berahyaluronidase alfa) in adults across most solid tumor indications for Keytruda. (Ref 1) ❓ How is this SC injection positioned against other approved SC anti-PD(L)1s? 🎯 Japan’s Ministry of Health, Labour and Welfare approved Novocure's Optune Lua (tumor treating fields) for concurrent use with PD-1/PD-L1 inhibitors for the Tx of adu

September 1st Week, 2025 Regulatory Events 🎯 China’s NMPA approved Boehringer Ingelheim’s zongertinib (HER2-selective tyrosine kinase inhibitor) monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic NSCLC whose tumors have activating HER2 mutations and who have received at least one line of prior systemic therapy. (Ref 1) ❓ What is the development status of the regimen in other key geographies? Clinical Events 🔬 The pivotal Phase

05/09/2025 CERo Therapeutics' CER-1236 received the FDA Fast Track Designation for AML (Ref) The US FDA granted the Fast Track Designation to CERo Therapeutics' CER-1236 (TIM-4 ligand targeting CER-T therapy) for the treatment of Acute Myeloid Leukemia (AML). Chris Ehrlich, CEO, CERo Therapeutics: “These FDA designations are important additional validation with regard to the urgency of the condition as well as the potential that the agency sees in the existing data as submitt

18/07/2025 ImCheck’s ICT01 received the Orphan Drug Designation for Acute Myeloid Leukemia (Ref) The US FDA granted the Orphan Drug Designation to ImCheck Therapeutics' ICT01 (anti-BTN3A) for the treatment of acute myeloid leukemia Stephan Braun, CMO, ImCheck Therapeutics: "Receiving FDA orphan drug designation for ICT01 is a significant recognition of ICT01’s innovative therapeutic potential to meet the urgent unmet medical needs of AML patients. This important regulatory m

May 5th & June 1st Week ⭐ Regulatory Updates 🎯 China’s NMPA granted Priority Review to CARsgen Therapeutics’ satri-cel (CT041; an autologous, anti-CLDN18.2 CAR-T) for ≥3L aGC/GEJA pts (Ref 1) ❓ What is the current landscape of cell therapies in GC? 🎯 Autolus Therapeutics’ obe-cel (an autologous, anti-CD-19 CAR-T) received a positive CHMP opinion in the EU for the treatment of R/R B-ALL in adults, based upon Ph1/2 FELIX/NCT04404660 study results (Ref 2) ❓ What are the ap

May 1st & 2nd Week, 2025 ⭐ Deals & Collaborations 🤝 NKure Therapeutics and CRISPR Therapeutics partnered to co-develop CRISPR’s CTX112 (an allogeneic, anti-CD19 CAR-T) for the treatment of R/R B-cell malignancies in India. NKure plans to seek the CDSCO approval by Jun’25 to begin Ph2 trials in India (Ref 1) ❓ What is the competitive landscape of CAR-Ts in India? 🤝 Chong Kun Dang Pharm. acquired a 7.3% stake in AbClon, and received priority rights to commercialize nespecab

April 3rd & 4th, 2025 Regulatory Updates 🎯 The UK MHRA granted conditional marketing authorization for Autolus Therapeutics’ Aucatzyl (obecabtagene autoleucel; an autologous, anti-CD19 CAR-T) for the treatment of adult R/R B-ALL patients based on the results from the Ph1/2 FELIX/NCT04404660 study (Ref 1) ❓ In what ways does Aucatzyl’s fast off-rate CD19 binding domain differentiate it from existing CD19 CAR-Ts for B-ALL? 🎯 Lyell Immunopharma received RMAT designation f

April 2nd April, 2025 ⭐ Regulatory Events 🎯 The US FDA cleared an IND application of CERo Therapeutics, Inc.’s CER-1236 (anti-Tim-4L chimeric engulfment receptor T-cell (CER-T)) for a Phase 1 trial in advanced solid tumors specifically NSCLC and ovarian cancer (Ref 1) ❓ What is the difference between CER-T and CAR-Ts and what benefits do CER-Ts offer? ⭐ Setbacks 🛑 Carisma Therapeutics paused R&D activities and is exploring strategic alternatives to maximize value, incl

Welcome to the May edition of our CGT Watch newsletter! CARsgen’s satri-cel priority review & Ph2 results; Autolus’ obe-cel positive CHMP opinion; BrainChild Bio’s BCB-276 RMAT; Gilead & Arcellx’s anito-cel Ph2 updated results; Senti Bio’s SENTI-202 updated Ph1 results; CARsgen’s CT0596 first-time Ph0 results; Artiva Bio’s AlloNK long-term Ph1/2 results; NeoImmuneTech’s NT-17 + CAR-T Ph1 topline results; Nkure and CRISPR Therapeutics partnership; Chong Kun Dang & AbClon part