04/11/2025 Merck and Blackstone enter into a $700M R&D funding agreement for Sacituzumab Tirumotecan ( Ref ) Merck & Co./MSD entered into an agreement to receive funds managed by Blackstone Life Sciences for the development of sacituzumab tirumotecan (sac-TMT; TROP2 ADC). Under the terms of the agreement, Blackstone will pay Merck $700 million (which is non-refundable, subject to termination provisions provided for in the agreement) to fund a portion of the development costs

October 5th Week, 2025 Regulatory Events   🎯 The EC approved Merck & Co./  MSD 's pembrolizumab (anti-PD-1) single agent as a neoadjuvant Tx followed by adjuvant pembrolizumab + RT ± cisplatin after surgery, and then as a single agent for adults with resectable LA SCCHN with PD-L1 CPS ≥1. (Ref 1) ❓ How is this approval expected to impact the treatment algorithm of LA SCCHN? Clinical Events 🔬 Merck & Co./ MSD  and  Eisai US  reported that the Phase 3 LITESPARK-011 trial of b

03/11/2025 Iovance's lifileucel TIL therapy elicited an ORR of 25.6% in previously treated non-sq NSCLC ( Ref ) Iovance Biotherapeutics reported interim data from its registrational Phase 2 IOV-LUN-202/NCT04614103 trial of lifileucel monotherapy (autologous TIL therapy) in patients with previously treated advanced non-squamous NSCLC without actionable genetic mutations. An ORR of 25.6% (CR: 5.1%) was achieved in a pool of 39 patients At a median follow up of 25.4 mos, the mDO

30/10/2025 Lantheus received FDA PDUFA Date for LNTH-2501 (Ga 68 edotreotide), a PET Diagnostic Imaging Kit ( Ref ) The US FDA established a PDUFA date for Lantheus Holdings' LNTH-2501 (Gallium-68 edotreotide) diagnostic kit indicated for use with PET imaging for localization of SSTR+ neuroendocrine tumors in adult and pediatric patients. The FDA has set a PDUFA target action date of March 29, 2026 Brian Markison, CEO, Lantheus: “ The development of LNTH-2501 underscores our

29/10/2025 Merck's perioperative Keytruda regimen received approval from the EC for LA SCCHN with PD-L1 CPS ≥1 ( Ref ) The European Commission (EC) has approved Merck & Co./MSD's pembrolizumab (anti-PD-1) single agent as a neoadjuvant Tx followed by adjuvant pembrolizumab + RT with or without cisplatin after surgery, and then as a single agent for adults with resectable locally advanced SCCHN with PD-L1 CPS ≥1. The approval follows a positive CHMP opinion, and is based on res

28/10/2025 Alphamab Oncology's JSKN003 received the FDA fast track designation for PROC ( Ref ) The US FDA granted the fast track designation to Alphamab Oncology's JSKN003 (biparatopic HER2-targeting antibody-drug conjugate) for the treatment of advanced or metastatic platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (PROC). To note, in Sep'24, Alphamab  entered a licensing agreement with JMT-Bio Technology (a wholly-

27/10/2025 Cellectar Biosciences' iopofosine I131 received the rare pediatric drug designation for pediatric high-grade glioma ( Ref ) The US FDA granted the rare pediatric drug designation (RPDD) to Cellectar Biosciences' iopofosine I131 in inoperable R/R pediatric high-grade glioma (pHGG). The FDA previously granted Orphan Drug Designation for iopofosine I 131 for the treatment of pHGG James Caruso, President and CEO, Cellectar: “ Receiving Rare Pediatric Disease Designatio

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

14/10/2025 Pfizer's tucatinib combination regimen significantly improved PFS as a 1L maintenance therapy in HER2+ve metastatic Breast Cancer ( Ref ) Per topline results from the Phase 3 HER2CLIMB-05 trial, Pfizer's tucatinib (tyrosine kinase inhibitor) in combination with first-line standard-of-care maintenance therapy (trastuzumab plus pertuzumab) following chemotherapy-based induction met its primary endpoint of PFS in HER2+ metastatic breast cancer. A statistically signifi