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

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

Highlights from the CHMP Dec 2025 Meeting are out! New Medicines 💊 Conditional marketing authorisation of ImmunityBio, Inc.'s nogapendekin alfa inbakicept (Anktiva: IL-15 superagonist complex) in combination with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours 💊 Jiangsu Hansoh Pharmaceutical Group Co., Ltd.’s aumolertinib (Aumseq

Highlights from the CHMP Nov 2025 Meeting are out! New Medicines 💊 Eli Lilly and Company's imlunestrant (Inluriyo: brain-penetrant oral ERα degrader) is indicated as monotherapy for the treatment of adult patients with ER+ve, HER2-ve, locally advanced or metastatic breast cancer with an activating ESR1-mutation, who have disease progression following prior treatment with an endocrine based regimen. New Hybrid Medicines 💊 Accord Healthcare's enzalutamide (Enzalutamide Accord

Highlights from the CHMP Oct 2025 Meeting are out! Indication Expansions 💊 Bristol Myers Squibb's lisocabtagene maraleucel (Breyanzi; autologous CD19-directed CAR T-cell therapy) is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor 💊 CStone Pharmaceuticals and Ewopharma's sugemalimab (Cejemly; anti-PD-L1) as monotherapy is indi

June 4th Week,2025 Regulatory Events 🎯 Daiichi Sankyo and AstraZeneca's Dato-DXd (Datroway; TROP2 ADC) has been granted an accelerated approval by the US FDA for the Tx of EGFR+ NSCLC patients previously treated with EGFR directed therapy and platinum-based chemotherapy. (Ref 1) ❓ Which other key regimens are expected to enter this setting in the near future? Special Designations ⭐ enGene's detalimogene voraplasmid (non-viral gene therapy) was granted a Regenerative Medici

June 3rd week, 2025 Regulatory Updates 🎯 Senti Biosciences received an ODD from the US FDA for SENTI-202 (off-the-shelf CD33 and/or FLT3 targeting CAR-NK) for R/R AML (Ref 1) 👉 Why it matters: This is the first logic-gated CAR-NK with clinical data, demonstrating encouraging early results (ORR of 71.4% (n=7) with responses sustained beyond 8 months) 🎯 The US FDA granted ODD for CERo Therapeutics, Inc.’ CER-1236 (anti-TIM-4L CER-T), which is being evaluated in Ph1...

March 1st Week, 2025 Regulatory Events 🎯 Bristol Myers Squibb’ nivolumab (anti-PD-1) + ipilimumab (anti-CTLA-4) has been approved by the EC as a first-line Tx for unresectable or advanced HCC. (Ref 1) ❓ How do the outcomes of nivolumab + ipilimumab compare against the previously approved Tx options for the first-line HCC? 🎯 Johnson & Johnson's amivantamab (EGFR x MET BsAb) + lazertinib (EGFR TKI) has been approved by the UK's MHRA for EGFR mutant, metastatic NSCLC. (Ref 2)

February 4th Week, 2025 📝 Merck & Co/ MSD's sBLA for neoadjuvant pembro followed by adjuvant pembro + RT ± cisplatin in resectable, LA SCCHN has been accepted by the US FDA for priority review (PDUFA date: Jun 23, 2025) (Ref 1) ❓ It is set to be the first approved Tx option for perioperative LA SCCHN. What are its challengers in the pipeline? 📝 BMS’ sBLA for nivo + ipi as a 1L Tx for adult and pediatric patients with unresectable or metastatic, MSI-H/dMMR colorectal canc

June 2nd week, 2025 ⭐ Deals & Collaborations 🤝Neowise Biotechnology granted BeOne Medicines rights to one of its proprietary antigen-specific TCR molecule under a non-exclusive licensing deal for the development of next-generation, iPSC-based off-the-shelf cell therapies for the Tx of Solid Tumors (Ref 1) ❓ What are the advantages of the off-the-shelf cell therapies? ⭐ Regulatory Updates 🎯 Myrio Tx received the US FDA approval for an IND application to initiate Ph1, N

February 3rd Week, 2025 📝 BMS’ Breyanzi (liso-cel; an autologous, anti-CD19 CAR-T) received NICE recommendation as an option for treating Relapsed or Refractory Large B-cell Lymphoma after first-line chemoimmunotherapy when a stem cell transplant is suitable (Ref 1) ❓ What new evidence led NICE to overturn its initial rejection of Breyanzi in Oct 2024? 📝 Anixa Biosciences received the approval to amend Ovarian Cancer Phase 1/NCT05316129 trial, allowing a second dose of FS

February 2nd Week, 2025 📝 BMS’ Phase 2 TRANSCEND FL trial of Breyanzi (lisocabtagene maraleucel; an autologous, anti-CD19 CAR-T) met primary endpoint of ORR and key secondary endpoint of CRR in marginal zone lymphoma (MZL) cohort. Detailed results will be presented at an upcoming conference (Ref 1, 2) ❓ What are the current benchmarks in MZL? 📝 Imugene’s Azer-cel (an allogeneic, anti-CD19 CAR-T) + low dose IL-2 elicited two additional complete responses resulting in a CRR o

Highlights from the CHMP May 2025 Meeting are out! ⭐ New Medicines 💊 Autolus Therapeutics' obecabtagene autoleucel (Aucatzyl; CD19 CAR-T cell therapy) for the treatment of adults from 26 years of age with R/R B cell precursor acute lymphoblastic leukaemia 👉 Positive opinion recommending the granting of a conditional marketing authorisation 💊 GSK's belantamab mafodotin (Blenrep; anti-BCMA ADC) for the treatment of adults with R/R multiple myeloma: 👉In combination with bort

Highlights from the CHMP Apr 2025 Meeting are out! ⭐ New Medicines 💊 Jazz Pharmaceuticals and BeiGene's zanidatamab (Ziihera; dual HER2-targeted BsAb) monotherapy is indicated for the treatment of adults with unresectable locally advanced or metastatic HER2+ve biliary tract cancer previously treated with at least one prior line of systemic therapy ⭐ New Biosimilars 💊 CuraTeQ Biologics' trastuzumab (Dazublys; HER2 inhibitor) is indicated for the treatment of HER2+ve metastat

Highlights from the CHMP March 2025 Meeting are out! ⭐ Indication Expansions: 💊 Pfizer's bosutinib (Bosulif; second-generation BCR-ABL TKI) use is extended to children aged 6 years and older with certain types of chronic myelogenous leukaemia, along with a new pharmaceutical form (hard capsules), associated with two new strengths (50 mg and 100 mg). 💊 AstraZeneca's acalabrutinib (Calquence; BTK inhibitor) + rituximab (anti-CD20 mAb) + bendamustine for the Tx of adult pati

Highlights from the CHMP Feb 2025 Meeting are out! Here are the positive recommendations in the Oncology space: ⭐ New Therapies: 👉 Regeneron's linvoseltamab (BCMA x CD3 BsAb) mono for the treatment of adult patients with R/R multiple myeloma who have received at least 3 prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38, and have demonstrated disease progression on the last therapy ⭐ Indication expansions: 👉 AstraZeneca's acalabru