February 2nd Week, 2026 Regulatory Events 🎯 The US FDA approved Merck & Co/ MSD 's Keytruda (pembrolizumab; anti-PD-1) as well as Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph subcutaneous product) in combination with paclitaxel, with or without bevacizumab, for adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS≥1), and who have received one or two prior systemic treatment

10/02/2026 Abbisko Therapeutics' irpagratinib received the FDA fast track designation for certain patients with HCC Merck's Keytruda/Keytruda Qlex regimen received FDA approval for PD-L1 positive Ovarian Cancer AstraZeneca & Daiichi's Phase 3 TROPION-Lung12 trial in stage I NSCLC has been discontinued Abbisko Therapeutics' irpagratinib received the FDA fast track designation for certain patients with HCC ( Ref ) The US FDA granted the fast track designation to Abbisko Therape

02/02/2026 OS Therapies initiated US FDA BLA filing for OST-HER2 for Osteosarcoma Exelixis' NDA for zanzalintinib + atezolizumab in mCRC has been accepted for review by the US FDA TuHURA Biosciences' IFx-2.0 received the FDA orphan drug designation for cutaneous Melanoma OS Therapies initiated US FDA BLA filing for OST-HER2 for Osteosarcoma ( Ref ) OS Therapies has initiated a BLA submission to the US FDA for OST-HER2 (HER2-bioengineered form of Listeria monocytogenes) in the

November 3rd Week, 2025 Regulatory Events 🎯 The EC granted approval to Merck & Co./ MSD 's subcutaneous formulation of pembrolizumab (KEYTRUDA SC, anti-PD-1) for use across all 33 KEYTRUDA indications for adult patients in Europe. (Ref 1) ❓ What are the key pros and cons of this SC formulation? 🎯 The EC granted approval to  Regeneron 's cemiplimab (anti-PD-1) as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma at high risk of recurrence after

21/11/2025 Pembrolizumab + enfortumab vedotin received the FDA approval for MIBC ( Ref ) The US FDA granted approval to Merck & Co./MSD pembrolizumab (anti-PD-1; both IV and SC formulations) in combination with Pfizer and Astellas' enfortumab vedotin (Nectin-4 ADC) as a neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, for the treatment of adult patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemothera

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

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

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. T

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

Highlights from the CHMP Sep 2025 Meeting are out! New Biosimilars 💊  Teva Pharmaceuticals ' Degevma (RANKL inhibitor; denosumab...

04/09/2025 Eli Lilly and Company's olomorasib in combination with Keytruda received the FDA Breakthrough Therapy designation...

August 3rd Week, 2025 Regulatory Events   🎯 Health Canada granted approval to Merck & Co./ MSD 's pembrolizumab (anti-PD-1) mono as a...

13/08/2025 Merck's perioperative Keytruda regimen received approval in Canada for resectable HNSCC with PD-L1 CPS ≥1 ( Ref ) Health...

12/08/2025 Perioperative pembrolizumab + enfortumab vedotin significantly improved EFS, OS and pCR in cisplatin-ineligible MIBC ( Ref )...

June 2nd Week, 2025 Regulatory Events   🎯 The US FDA approved Merck & Co./ MSD 's pembrolizumab (anti-PD-1) mono Q3W, 2Cy, as a...

May 3rd Week, 2025 Regulatory Events   🎯  Incyte  and  MacroGenics, Inc. ’s retifanlimab (anti-PD-1) + carboplatin + paclitaxel has been...

April 2nd Week, 2025 Regulatory Events   🎯 AstraZeneca  and  Daiichi Sankyo ’s trastuzumab deruxtecan (HER2 ADC) mono has been approved...

March 4th Week, 2025 Regulatory Events 🎯  CStone Pharmaceuticals  submitted a Type II variation application to the EMA for sugemalimab...

March 3rd Week, 2025 Regulatory Events   🎯 The US FDA granted traditional approval to Merck & Co./ MSD ’s pembrolizumab (anti-PD-1) +...

12/06/2025 MAIA Biotechnology and Roche announce a master clinical supply agreement for hard-to-treat cancer therapies ( Ref ) MAIA...