November 1st Week, 2025 Regulatory Events 🎯 The US FDA approved  Johnson & Johnson 's Darzalex Faspro (daratumumab, an anti-CD38, and hyaluronidase) as a single agent treatment for adult patients with high-risk smoldering multiple myeloma (HR-SMM). (Ref 1) ❓ How is this approval expected to impact the treatment algorithm of this indication? Clinical Events 🔬 In the registrational cohort of the Phase 2 IOV-LUN-202/NCT04614103 trial,  Iovance Biotherapeutics, Inc. ’s lifileuc

10/11/2025 Boehringer Ingelheim's zongertinib received the Commissioner’s National Priority Voucher for HER2-mutant NSCLC ( Ref ) The US FDA awarded a Commissioner’s National Priority Voucher (CNPV) to Boehringer Ingelheim's zongertinib (HER2 TKI) for the treatment of patients with HER2-mutant NSCLC.  Boehringer Ingelheim is planning a sNDA for zongertinib in the first-line treatment of patients with HER2-mutant NSCLC Previously, zongertinib received accelerated approval by t

06/11/2025 Johnson & Johnson's Darzalex Faspro has been approved by the FDA for HR-SMM ( Ref ) The US FDA approved Johnson & Johnson's Darzalex Faspro® (daratumumab and hyaluronidase-fihj) as a single agent treatment for adult patients with high-risk smoldering multiple myeloma (HR-SMM). The approval is based on results from the Ph3 AQUILA/NCT03301220 trial, which evaluated the efficacy and safety of Darzalex Faspro vs active monitoring (or “Watch and Wait”) in patients with

05/11/2025 Leukogene Therapeutics' LTI-214 received the FDA orphan drug designation for AML ( Ref ) The US FDA granted the orphan drug designation to Leukogene Therapeutics' LTI-214 (M2T-CD33; myeloid-targeted immunotherapy) for the treatment of Acute Myeloid Leukemia (AML). Sandeep Gupta, CEO, Leukogene: “ We are honored that the FDA has recognized the therapeutic promise of LTI-214 by granting Orphan Drug Designation. AML remains one of the most challenging hematologic canc

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

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

09/10/2025 Adcendo's ADCE-D01 received the FDA fast track designation for the treatment of STS ( Ref ) The US FDA granted the fast track...

07/10/2025 Precision NeuroMed's cinetredekin besudotox received the FDA orphan drug designation for GBM ( Ref ) The US FDA granted the...

October 1st Week, 2025 Regulatory Events 🎯 The US FDA approved  Jazz Pharmaceuticals ' lurbinectedin (DNA alkylating agent) +  Roche 's...

06/10/2025 Orca Bio's BLA for Orca-T accepted for Priority Review to treat Hematological Malignancies ( Ref ) The US FDA accepted Orca...

September 4th Week, 2025 Regulatory Events 🎯 The US FDA approved  Eli Lilly and Company 's imlunestrant (oral estrogen receptor...

29/09/2025 In an ~$8B deal, Genmab will acquire Merus in an all-cash transaction ( Ref ) Genmab and Merus announced a transaction...

25/09/2025 Eli Lilly and Company's Inluriyo has been approved in the US for ER+, HER2–, ESR1-mutated breast cancer ( Ref ) The US FDA...

24/09/2025 AstraZeneca and Daiichi's trastuzumab deruxtecan + pertuzumab received priority review status for first-line HER2+ve breast...

23/09/2025 Kelun Biotech's NDA for A400/EP0031 in RET +ve NSCLC was accepted by China's NMPA ( Ref ) China's NMPA has accepted Sichuan...

22/09/2025 Nuvalent completed the NDA submission to the FDA for zidesamtinib in ROS +ve NSCLC ( Ref ) Nuvalent, Inc has completed its NDA...

19/09/2025 Merck & Co/MSD received positive EU CHMP Opinions for perioperative pembrolizumab regimen in SCCHN, and for subcutaneous...