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 (Au

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 Ac

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 i

October 2nd Week, 2025 Regulatory Events 🎯 The US FDA approved  Regeneron 's cemiplimab (PD-1 inhibitor) as an adjuvant Tx for adult patients with cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation. (Ref 1) ❓ How is this approval expected to impact the Tx paradigm of this indication? 🎯 The US FDA accepted for Priority Review  Orca Bio 's BLA seeking approval of Orca-T (allogeneic T-cell immunotherapy) as a Tx of hematological malignanci

September 2nd Week, 2025 Regulatory Events 🎯 The US FDA approved  Johnson & Johnson Innovative Medicine 's INLEXZO (TAR-200; gemcitabine...

September 1st Week, 2025 Regulatory Events 🎯 China’s NMPA approved  Boehringer Ingelheim ’s zongertinib (HER2-selective tyrosine kinase...

02/09/2025 Replimune has scheduled a Type A Meeting with the FDA for the CRL of RP1 + nivo in advanced melanoma ( Ref )   Replimune...

August 4th Week, 2025 Regulatory Events   🎯 The EC approved  BeOne Medicines ' tislelizumab (anti-PD-1) + platinum-containing chemo as...

August 4th Week, 2025 Regulatory Events   🎯 Health Canada issued a NOC/c for  Iovance Biotherapeutics, Inc. 's lifileucel (autologous...

August 3rd Week, 2025 Regulatory Events   🎯 Health Canada granted approval to Merck & Co./ MSD 's pembrolizumab (anti-PD-1) mono as a...

August 1st Week, 2025 Regulatory Events   🎯  AbbVie  submitted a sNDA to the US FDA for AbbVie and  Roche ’s venetoclax (BCL-2...

June 4th Week,2025 Regulatory Events   🎯  Daiichi Sankyo  and  AstraZeneca 's Dato-DXd (Datroway; TROP2 ADC) has been granted an...

Highlights from the CHMP June 2025 Meeting are out! New Medicines 💊  Cordex Biologics ' (an  ExCellThera  company) dorocubicel...

May 3rd Week, 2025 Regulatory Events   🎯  Incyte  and  MacroGenics, Inc. ’s retifanlimab (anti-PD-1) + carboplatin + paclitaxel has been...

May 2nd Week, 2025 Special Designations ⭐ The US FDA granted the Fast Track designation to  Adcentrx Therapeutics ’ ADRX-0706 (Nectin-4...

April 4th Week, 2025 Regulatory & Market News 🎯  Akeso Biopharma ’s penpulimab-kcqx (anti-PD-1) + chemo received the US FDA approval for...

April 2nd Week, 2025 Regulatory Events   🎯 AstraZeneca  and  Daiichi Sankyo ’s trastuzumab deruxtecan (HER2 ADC) mono has been approved...

March 4th Week, 2025 Regulatory Events 🎯  CStone Pharmaceuticals  submitted a Type II variation application to the EMA for sugemalimab...

March 2nd Week, 2025 Mergers & Acquisitions 🤝  Checkpoint Therapeutics Inc  is set to be acquired by  SUN PHARMA , an Indian pharma...