31/05/2026 Johnson & Johnson submits US sBLA for subcutaneous amivantamab in HPV-unrelated R/M HNSCC, previously treated with immunotherapy and chemotherapy Johnson & Johnson submits US sBLA for subcutaneous amivantamab in HPV-unrelated R/M HNSCC, previously treated with immunotherapy and chemotherapy (Ref) Johnson & Johnson confirmed that a supplemental Biologics License Application (sBLA) has been submitted to the US FDA seeking approval of subcutaneous amivantamab (EGFR x

May 1st Week, 2026 Regulatory Events 🎯 Pierre Fabre Laboratories aligned with the US FDA for resubmission of the BLA for tabelecleucel (allogeneic T‑cell therapy) for R/R EBV+ post‑transplant lymphoproliferative disease who have received at least one prior therapy including an anti-CD20 containing regimen (Ref 1) ❓ How is tabelecleucel positioned in the current Lymphoma market landscape? 🎯 Nuvation Bio’s supplemental NDA with updated data for taletrectinib (IBTROZI®; TK

07/04/2026 Corbus Gains FDA Alignment on CRB‑701 Registrational Trials in HNSCC and Cervical Cancer Nuvalent Submits NDA for Neladalkib in ALK+ NSCLC NextCure Receives Fast Track Designation for SIM0505 (CDH6 ADC) in Ovarian Cancer Corbus Gains FDA Alignment on CRB‑701 Registrational Trials in HNSCC and Cervical Cancer (Ref) Corbus reached broad agreement with the FDA on the registration path for CRB-701, a next-generation Nectin-4 targeting antibody-drug conjugate (ADC), in

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

16/09/2025 Corbus and CSPC Pharma's CRB-701 ADC received the FDA Fast Track Designation for R/M HNSCC (Ref) The US FDA granted the Fast Track Designation to Corbus Pharmaceuticals and CSPC Pharma's CRB-701 (Nectin-4 targeting ADC) for the treatment of R/M HNSCC previously treated with platinum-based chemo and an anti-PD(L)-1. Results from the dose optimization part of Phase 1/2 CRB-701-01/NCT06265727 trial will be presented at ESMO 2025 Previously, the ADC received a Fast Tra

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

13/08/2025 Merck's perioperative Keytruda regimen received approval in Canada for resectable HNSCC with PD-L1 CPS ≥1 (Ref) 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. The approval is based on results from the Phase 3 KEYNOTE-689 trial in

29/07/2025 Calidi Biotherapeutics' CLD-201 received the US FDA Fast Track Designation for soft tissue sarcoma (Ref) The US FDA granted the Fast Track designation to Calidi Biotherapeutics' CLD-201 (SuperNova; allogeneic adipose stem-cell loaded oncolytic virus) for the treatment of soft tissue sarcoma. Guy Travis Clifton, CMO, Calidi: “FDA IND clearance and Fast Track designation represents an important milestone in the development of CLD-201. This designation underscores the

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 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

February 4th Week, 2025 📝 Merck & Co/ MSD's sBLA for neoadjuvant pembro followed by adjuvant pembro + RT ± cisplatin in resectable, LA SCCHN has been accepted by the US FDA for priority review (PDUFA date: Jun 23, 2025) (Ref 1) ❓ It is set to be the first approved Tx option for perioperative LA SCCHN. What are its challengers in the pipeline? 📝 BMS’ sBLA for nivo + ipi as a 1L Tx for adult and pediatric patients with unresectable or metastatic, MSI-H/dMMR colorectal canc

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