August 1st Week, 2026 Regulatory Events 🎯 The US FDA granted an accelerated approval to Replimune's vusolimogene oderparepvec-wtpg (TUDRIQEVTM/RP1; oncolytic viral therapy) + Bristol Myers Squibb and Ono Pharma's nivolumab (Opdivo; anti-PD-1) for the Tx of adults with unresectable advanced cutaneous melanoma with disease progression on prior anti-PD-1 based regimen (Ref) ❓ How is this approval expected to impact the ≥2L Melanoma Tx paradigm? 🎯 Dr. Reddy's Laboratories ri

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

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 malignancies i

September 2nd Week, 2025 Regulatory Events 🎯 The US FDA approved Johnson & Johnson Innovative Medicine's INLEXZO (TAR-200; gemcitabine intravesical system) for the Tx of adults with BCG-unresponsive, non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors (Ref 1) ❓ How is this approval expected to impact the Tx paradigm? 🎯 The US FDA accepted Corcept Therapeutics' NDA for relacorilant (selective glucocorticoid receptor antagonist) as a Tx

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

02/09/2025 Replimune has scheduled a Type A Meeting with the FDA for the CRL of RP1 + nivo in advanced melanoma (Ref) Replimune announced that a Type A meeting with the US FDA has been scheduled to discuss the CRL for the BLA of vusolimogene oderparepvec (RP1; herpes simplex virus engineered and genetically armed with GALV-GP R- and GM-CSF) + nivolumab for the treatment of advanced melanoma. Replimune submitted a briefing book to the FDA addressing the points from the CRL T

August 4th Week, 2025 Regulatory Events 🎯 The EC approved BeOne Medicines' tislelizumab (anti-PD-1) + platinum-containing chemo as neoadjuvant Tx followed by tislelizumab monotherapy as adjuvant Tx for resectable NSCLC at high risk of recurrence. (Ref 1) ❓ How is BeOne’s regimen positioned compared to other approved perioperative options? Clinical Events 🔬 Per final analysis of the Phase 3 HARMONi-A trial, a statistically significant and clinically meaningful OS benef

August 4th Week, 2025 Regulatory Events 🎯 Health Canada issued a NOC/c for Iovance Biotherapeutics, Inc.'s lifileucel (autologous TIL therapy) for adult patients with unresectable or metastatic melanoma that has progressed on or after at least one prior systemic therapy including an anti-PD-1, and if BRAF V600 mutant, BRAF inhibitor ± MEK inhibitor, and who have no satisfactory alternative treatment options. (Ref 1) ❓ How is this approval going to impact the Melanoma treat

August 3rd Week, 2025 Regulatory Events 🎯 Health Canada granted approval to Merck & Co./MSD's pembrolizumab (anti-PD-1) mono as a neoadjuvant treatment, then continued as adjuvant treatment in combination with RT +/- cisplatin and then as monotherapy for adult patients with resectable locally advanced HNSCC with PD-L1 CPS ≥1. (Ref 1) ❓ What were the clinical outcomes that supported the approval? Clinical Events 🔬 The Phase 3 KEYNOTE-905/EV-303 trial of Merck & Co./MSD's

August 1st Week, 2025 Regulatory Events 🎯 AbbVie submitted a sNDA to the US FDA for AbbVie and Roche’s venetoclax (BCL-2 inhibitor) + acalabrutinib (fixed-duration, all-oral combo) in previously untreated patients with chronic lymphocytic leukemia. (Ref 1) ❓ What are the combo’s pros and cons vs approved CLL therapies? Clinical Events 🔬 Eli Lilly and Company’s Phase 3 BRUIN CLL-314 trial of pirtobrutinib (non-covalent, reversible BTK inhibitor) vs ibrutinib (covalent

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

Highlights from the CHMP June 2025 Meeting are out! New Medicines 💊 Cordex Biologics' (an ExCellThera company) dorocubicel (Zemcelpro; UM171 Cell Therapy) has been recommended for a conditional marketing authorisation for the treatment of adult patients with haematological malignancies requiring an allogeneic haematopoietic stem cell transplantation following myeloablative conditioning for whom no other type of suitable donor cells is available. Indication Expansions 💊 Exel

May 3rd Week, 2025 Regulatory Events 🎯 Incyte and MacroGenics, Inc.’s retifanlimab (anti-PD-1) + carboplatin + paclitaxel has been approved by the US FDA for the first-line Tx of inoperable, locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). Retifanlimab has also been approved as a single agent for the Tx of locally recurrent or metastatic SCAC with disease progression on or intolerance to platinum-based chemo. (Ref 1) ❓ What is the status of

May 2nd Week, 2025 Special Designations ⭐ The US FDA granted the Fast Track designation to Adcentrx Therapeutics’ ADRX-0706 (Nectin-4 ADC) for the Tx of locally advanced or metastatic squamous cell cervical cancer. (Ref 1) ❓ What are the outcomes of ADRX-0706 that supported the Fast Track designation? ⭐ The US FDA granted the Fast Track designation to Glenmark Pharmaceuticals (Ichnos Glenmark Innovation)’s ISB2001 (BCMA x CD38 x CD3 trispecific antibody) for the Tx of R/R mu

April 4th Week, 2025 Regulatory & Market News 🎯 Akeso Biopharma’s penpulimab-kcqx (anti-PD-1) + chemo received the US FDA approval for the Tx of previously untreated recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (nkNPC). 👉 The FDA also approved single agent penpulimab-kcqx for the Tx of nkNPC patients who have progressed following platinum chemo and at least one other prior line of therapy. (Ref 1) ❓ How does this approval affect the current Tx landscape

April 2nd Week, 2025 Regulatory Events 🎯AstraZeneca and Daiichi Sankyo’s trastuzumab deruxtecan (HER2 ADC) mono has been approved in the EU for the Tx of unresectable/metastatic HR+ve, HER2-low/ultralow breast cancer patients who have received at least one endocrine Tx in the metastatic setting and who are not suitable for endocrine Tx as the next line of Tx. (Ref 1) ❓What is the status of trastuzumab deruxtecan for these patients in other key markets? 🎯AstraZeneca and D