18/02/2026 ImmunityBio's ANKTIVA® + BCG received conditional marketing authorization in Europe for BCG-unresponsive NMIBC CIS Johnson & Johnson's subcutaneous amivantamab received the FDA Breakthrough Therapy Designation for HPV-unrelated R/M SCCHN ImmunityBio's ANKTIVA® + BCG received conditional marketing authorization in Europe for BCG-unresponsive NMIBC CIS (Ref) The EC granted conditional marketing authorization to ImmunityBio's ANKTIVA® (nogapendekin alfa inbakicept) +

21/01/2026 BioNTech's BNT113 + pembro received the FDA fast track designation for HPV16+ R/M SCCHN with PD-L1 CPS ≥1 Wugen's soficabtagene geleucel received the FDA Breakthrough Therapy Designation for T cell malignancies Opna Bio's zavabresib received the FDA orphan drug designation for myelofibrosis BioNTech's BNT113 + pembro received the FDA fast track designation for HPV16+ R/M SCCHN with PD-L1 CPS ≥1 (Ref) The US FDA granted the fast track designation to BioNTech's BNT11

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 belzuti

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 resul

13/10/2025 Bicara Therapeutics' ficerafusp alfa + pembro received the breakthrough therapy designation for PD-L1 CPS ≥1, R/M SCCHN pts excluding HPV+ve OSCC (Ref) The US FDA granted the breakthrough therapy designation to Bicara Therapeutics' ficerafusp alfa (EGFR x TGF-β bifunctional antibody) in combination with pembrolizumab for the first line treatment of patients with R/M HNSCC whose tumors express PD-L1 CPS ≥1, excluding HPV+ve oropharyngeal squamous cell carcinoma. The

19/09/2025 Merck & Co/MSD received positive EU CHMP Opinions for perioperative pembrolizumab regimen in SCCHN, and for subcutaneous administration (Ref) The EMA's CHMP adopted a positive opinion recommending the approval of Merck & Co./MSD's pembro (anti-PD-1) mono as a neoadjuvant Tx followed by adjuvant pembro + RT ± cisplatin after surgery, then pembro mono for resectable locally advanced SCCHN with PD-L1 CPS ≥1. The recommendation is based on results from the Ph3 KEYNOTE

September 3rd Week, 2025 Regulatory Events 🎯 The US FDA approved Merck & Co/MSD’s Keytruda Qlex (subcutaneous injection of pembrolizumab and berahyaluronidase alfa) in adults across most solid tumor indications for Keytruda. (Ref 1) ❓ How is this SC injection positioned against other approved SC anti-PD(L)1s? 🎯 Japan’s Ministry of Health, Labour and Welfare approved Novocure's Optune Lua (tumor treating fields) for concurrent use with PD-1/PD-L1 inhibitors for the Tx of adu

Highlights from the CHMP Sep 2025 Meeting are out! New Biosimilars 💊 Teva Pharmaceuticals' Degevma (RANKL inhibitor; denosumab biosimilar) is indicated for prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced cancer involving bone and for the treatment of adults and skeletally mature adolescents with giant cell tumour of bone 💊 Reddy Holding GmbH's Xbonzy (RANKL inhibitor; denosu

25/08/2025 Quest Diagnostics' Haystack MRD® test received the Breakthrough Device Designation from the FDA for colorectal cancer (Ref) The US FDA granted the Breakthrough Device Designation for Quest Diagnostics' Haystack MRD® test for identifying MRD-positive patients with stage II colorectal cancer following curative-intent surgical treatment who may benefit from adjuvant therapy in accordance with therapeutic product labeling. Dan Edelstein, Vice President and General Mana

August 2nd Week, 2025 Regulatory Events 🎯 The US FDA granted accelerated approval to Boehringer Ingelheim's zongertinib (kinase inhibitor) for previously treated, unresectable/metastatic non-sqNSCLC with HER2 TKD activating mutations. (Ref 1) ❓ What proportion of NSCLC patients have HER2 TKD activating mutations? 🎯 The US FDA granted accelerated approval to Jazz Pharmaceuticals' dordaviprone (DRD2 antagonist and ClpP agonist) for previously treated, H3 K27M-mutant, diff

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

05/08/2025 Immutep received positive feedback from the FDA for the late-stage development of Eftilagimod Alfa in SCCHN (Ref) Immutep received positive and constructive feedback from the US FDA regarding future clinical development of eftilagimod alpha (soluble LAG-3 protein) as a first-line Tx of R/M SCCHN with PD-L1 CPS <1. Based on available data from cohort B of the Ph2b TACTI-003 trial of efti + pembro in R/M SCCHN with CPS <1, the FDA agreed on the potential of the comb

30/07/2025 Phase 3 COSTAR Lung trial of dostarlimab + docetaxel ± cobolimab failed to meet the OS endpoint in previously treated NSCLC (Ref) GSK's Phase 3 COSTAR Lung/NCT04655976 trial of dostarlimab (anti-PD-1) + docetaxel ± cobolimab (anti-TIM-3) combinations did not meet the primary endpoint of improving OS vs docetaxel alone in advanced NSCLC that has progressed on prior PD-(L)1 therapy and chemotherapy. All regimens were well tolerated and toxicities were consistent with

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

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 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

15/05/2025 Another TIGIT agent fails as iTeos and GSK terminate the belrestotug development program based on disappointing NSCLC and SCCHN trials (Ref 1, Ref 2) iTeos Therapeutics and GSK announced topline results from an updated interim analysis of the Ph2 GALAXIES Lung-201 trial of iTeos & GSK's belrestotug (anti-TIGIT) + GSK & Anaptys' dostarlimab (anti-PD-1) as a first-line Tx of unresectable, locally advanced or metastatic NSCLC with PD-L1 ≥50%, in which clinically meani

29/04/2025 ALX Oncology’s Phase 2 ASPEN-03 & ASPEN-04 trials failed to meet the primary endpoint of ORR (Ref 1) ALX Oncology hit with a double blow in first-line R/M SCCHN as their Phase 2 ASPEN-03 & ASPEN-04 trials evaluating evorpacept, a CD47-blocker, in combination with pembrolizumab with or without chemotherapy did not meet the primary endpoints of improved ORR. While data showed trends in improvement versus historical controls, the signals were not strong enough to adva