04/07/2025 Imfinzi has been approved by the EC as a perioperative immunotherapy for muscle-invasive bladder cancer (Ref) AstraZeneca’s neoadjuvant durvalumab (Imfinzi; anti-PD-L1) in combination with gemcitabine and cisplatin followed by adjuvant durvalumab monotherapy after radical cystectomy for adult patients with resectable muscle-invasive bladder cancer (MIBC) has been approved in the EU The approval follows the positive CHMP opinion and is based on results from the Phas

02/07/2025 Lynozyfic received accelerated approval from the US FDA for R/R Multiple Myeloma (Ref) Regeneron Pharmaceuticals announced that the US FDA granted accelerated approval for linvoseltamab-gcpt (Lynozyfic; BCMA x CD3 bispecific antibody) for patients with relapsed or refractory (R/R) multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti‑CD38 monoclonal antibody The accelerated a

01/07/2025 HanchorBio and Henlius signed a ~$200M licensing deal for HanchorBio's HCB101 (Ref) HanchorBio and Shanghai Henlius Biotech signed an out-licensing agreement which granted Henlius the exclusive development and commercialization rights to HanchorBio's HCB101 (SIRPα-IgG4 Fc fusion protein) across Greater China (including Mainland China, Hong Kong, and Macau), key Southeast Asian countries, as well as all countries in the Middle East and North Africa (MENA) Under the

📢 AbbVie is set to acquire University of Pennsylvania’s spinout, Capstan Therapeutics for up to $2.1 billion in cash, representing one of the major acquisitions in the CGT space in 2025. ⭐ The acquisition price represents a significant premium over Capstan's last valuation, however, with this deal AbbVie gains full access to Capstan's key programs and most importantly its proprietary in vivo cell engineering technology, which was developed by the world-renowned scientists. ⭐

30/06/2025 Revolution Medicines and Summit entered into a clinical collaboration to evaluate RAS(ON) inhibitors and ivonescimab combinations in RAS Mutant Tumors (Ref) Revolution Medicines and Summit Therapeutics entered into a clinical collaboration to evaluate the safety and efficacy of Revolution Medicines’ daraxonrasib (multi-selective RAS(ON) inhibitor), zoldonrasib (G12D-selective inhibitor) and elironrasib (G12C-selective inhibitor), in combination with Akeso & Summit

24/06/2025 CARsgen Therapeutics submitted a NDA for Satri-cel to China’s NMPA (Ref) CARsgen Therapeutics submitted the New Drug Application (NDA) for satricabtagene autoleucel (satri-cel; an autologous anti-Claudin18.2 CAR-T) to the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the treatment of Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) in patients who have failed at least two prior

24/06/2025 Opdivo + Yervoy received supplemental approval in Japan to expand the use for unresectable hepatocellular carcinoma (Ref) Ono Pharmaceutical and Bristol-Myers Squibb K.K. have received a supplemental approval of Opdivo (nivolumab; anti-PD-1) + Yervoy (ipilimumab; anti-CTLA-4) in Japan, to expand the use for the treatment of unresectable hepatocellular carcinoma (HCC) The approval is based on the results from the global Phase 3 CheckMate-9DW trial of nivo + ipi vs i

23/06/2025 Datroway has been approved in the US for locally advanced or metastatic EGFR-mutated NSCLC (Ref) The US FDA approved AstraZeneca and Daiichi's datopotamab deruxtecan (Datroway; TROP2 ADC) for the treatment of adult patients with locally advanced or metastatic EGFR-mutated NSCLC who have received prior EGFR-directed therapy and platinum-based chemotherapy. The indication is approved under accelerated approval based on ORR and DoR results from a subgroup analysis of

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

22/06/2025 The Phase 3 STELLAR-303 trial of zanzalintinib + atezolizumab achieved significant OS benefit in metastatic colorectal cancer (Ref) Per topline results from the Phase 3 STELLAR-303/NCT05425940 pivotal trial, Exelixis' zanzalintinib (third-generation oral tyrosine kinase inhibitor) + Roche's atezolizumab (aPD-L1) demonstrated a statistically significant improvement in OS vs regorafenib in previously treated, non-microsatellite instability (MSI)-high metastatic color

19/06/2025 Initial patient screening completed in Transgene's Phase 2 trial of TG4050 vaccine in resectable SCCHN (Ref) Transgene completed the initial patient screening in the randomized Phase 2 part of its Phase 1/2 TG4050.02/NCT04183166 trial evaluating TG4050 (individualized neoantigen vaccine) mono as an adjuvant Tx of HPV-ve SCCHN In Ph1 part of the trial, the vaccine elicited promising outcomes with a 2-yr DFS rate of 100.0% Transgene expects to complete randomization

18/06/2025 The Phase 3 IDeate-Prostate01 trial of ifinatamab deruxtecan has been initiated in pretreated, metastatic CRPC patients (Ref) The first patient has been dosed in the Phase 3 IDeate-Prostate01/NCT06925737 trial evaluating Daiichi Sankyo and Merck & Co./MSD's ifinatamab deruxtecan (I-DXd; B7-H3 ADC) vs docetaxel in patients with metastatic castration-resistant prostate cancer (CRPC) with disease progression during or after treatment with an androgen receptor pathway

June 3rd Week, 2025 Regulatory Events 🎯 The US FDA approved the updated labelling of Pfizer’s talazoparib (PARP inhibitor) + enzalutamide (androgen receptor inhibitor) for mCRPC to include the final OS data for the combo’s existing indication for the Tx of HRR gene-mutated mCRPC, but did not expand the indication to include non-HRR gene mutated patients. (Ref 1) ❓ What were the key factors that influenced the FDA’s decision to not expand the indication? 🎯 The US FDA appr

June 2nd Week, 2025 Regulatory Events 🎯 The US FDA approved Merck & Co./MSD's pembrolizumab (anti-PD-1) mono Q3W, 2Cy, as a neoadjuvant Tx followed by adjuvant pembro Q3W, 3Cy + RT ± cisplatin after surgery, then pembro mono Q3W, 12Cy, for adults with resectable locally advanced SCCHN with PD-L1 CPS ≥1. (Ref 1) ❓ What were the factors that influenced the FDA’s decision to limit the label to PD-L1 CPS ≥1? 🎯 The US FDA approved Nuvation Bio’s taletrectinib (ROS1 inhibitor)

May 5th Week, 2025 Regulatory Events 🎯 The EC approved Bristol Myers Squibb’s subcutaneous nivolumab (Opdivo Quantig; anti-PD-1) co-formulated with Halozyme, Inc.’s recombinant human hyaluronidase (rHuPH20) for use across multiple adult solid tumors as monotherapy, monotherapy maintenance following completion of nivolumab + ipilimumab IV, or in combination with chemotherapy or cabozantinib. (Ref 1) ❓ What is the development status of other key subcutaneous immune checkpoint

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

May 1st Week, 2025 Regulatory Events 🎯 Summit Therapeutics, Inc. and Akeso Biopharma’s ivonescimab (PD-1 x VEGF BsAb) mono has been approved in China for the 1L Tx of NSCLC with PD-L1 ≥1%. (Ref 1) ❓ When can we expect ivonescimab to receive the first approval in the key markets? 🎯 The UK’s MHRA approved Bristol Myers Squibb’s nivolumab (anti-PD-1) subcutaneous formulation for a broad range of cancers, including kidney, melanoma, lung, head and neck, bladder, colorectal,

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 3rd Week, 2025 Regulatory Events 🎯 Bristol Myers Squibb’s nivolumab (anti-PD-1) + ipilimumab (anti-CTLA-4) has been approved by the US FDA as a first-line Tx of unresectable/metastatic hepatocellular carcinoma. (Ref 1) ❓ What portion of the first-line HCC patients are anticipated to transition to the nivolumab + ipilimumab regimen? 🎯 ImmunityBio, Inc. completed the sBLA submission to the US FDA for nogapendekin alfa inbakicept (IL-15 superagonist fusion protein) + B