29/06/2026 Genmab & AbbVie's epcoritamab + lenalidomide combination meets primary endpoint of PFS in Phase 3 DLBCL trial Samsung Bioepis’ Keytruda biosimilar SB27 demonstrates Phase 1 and Phase 3 equivalence in NSCLC trials MHRA validates Eisai and Nuvation Bio's taletrectinib MAA in UK, expanding ROS1+ NSCLC access Genmab & AbbVie's epcoritamab + lenalidomide combination meets primary endpoint of PFS in Phase 3 DLBCL trial (Ref) Genmab announced positive topline results from

24/06/2026 US FDA approved sacituzumab govitecan-hziy as monotherapy and in combination with pembrolizumab for first-line treatment of triple-negative breast cancer (TNBC) EU approves KEYTRUDA + Padcev as first PD-1 + ADC perioperative regimen for cisplatin-ineligible MIBC IBRANCE secures US FDA approval as the first CDK4/6 inhibitor for HR+, HER2+ metastatic breast cancer maintenance US FDA approved sacituzumab govitecan-hziy as monotherapy and in combination with pembrolizu

15/05/2026 FDA approved ENHERTU (fam-trastuzumab deruxtecan-nxki) for the treatment of neoadjuvant and adjuvant HER2+ early breast cancer UGN-103 delivers 94.5% six‑month durability in Phase 3 UTOPIA trial, with NDA submission planned for Q3 2026 to advance next‑generation RTGel therapy in recurrent LG‑IR‑NMIBC In Ph3 trial, Regeneron’s fianlimab + cemiplimab showed numeric PFS gain but missed statistical significance vs pembrolizumab in advanced or metastatic Melanoma CAN‑24

14/05/2026 Alembic secures USFDA tentative nod for Darolutamide tablets, 300 mg In Ph3 VOLGA trial, durvalumab + enfortumab vedotin significantly improved EFS and OS in MIBC Celcuity expands Phase 3 VIKTORIA-2 trial to include endocrine‑sensitive HR+/HER2‑ breast cancer patients Astellas files sNDA in Japan for PADCEV + Keytruda in cisplatin‑eligible muscle‑invasive bladder cancer, backed by Phase 3 EV‑304 survival benefit Alembic secures USFDA tentative nod for Darolutamide

08/05/2026 FDA grants RMAT designation to RZ-001, Algenomics’ RNA-based gene therapy for hepatocellular carcinoma, accelerating U.S. development and global partnership opportunities Sacituzumab tirumotecan + pembrolizumab gains NMPA priority review after landmark Phase III success in first‑line PD‑L1+ NSCLC FDA grants RMAT designation to RZ-001, Algenomics’ RNA-based gene therapy for hepatocellular carcinoma, accelerating U.S. development and global partnership opportunities

20/04/2026 Arcus halts Lung Cancer Trial With Gilead After Futility Analysis FDA granted Fast Track designation for Lunresertib + Zedoresertib in Platinum-Resistant Ovarian Cancer FDA Grants Orphan Drug Status to Orion’s ODM-212 for Mesothelioma FDA Grants Priority Review for PADCEV + Keytruda in Muscle-Invasive Bladder Cancer Arcus halts Lung Cancer Trial With Gilead After Futility Analysis (Ref) Arcus Biosciences has halted its Phase 3 lung cancer trial with Gilead Sciences

02/04/2026 Merck & Co./MSD's pembrolizumab + paclitaxel ± bevacizumab received the EC approval for Platinum-Resistant Recurrent Ovarian Carcinoma Context Therapeutics' CTIM-76 received the FDA fast track designation for platinum-resistant ovarian cancer AstraZeneca's Phase 3 EMERALD-3 trial met the PFS endpoint in embolisation-eligible unresectable HCC Merck & Co./MSD's pembrolizumab + paclitaxel ± bevacizumab received the EC approval for Platinum-Resistant Recurrent Ovarian

13/03/2026 Immutep's Phase 3 TACTI-004 trial of eftilagimod alfa regimen in 1L NSCLC NSCLC has been discontinued Immutep's Phase 3 TACTI-004 trial of eftilagimod alfa regimen in 1L NSCLC NSCLC has been discontinued (Ref) Based on the Independent Data Monitoring Committee (IDMC) recommendation, Immutep's Phase 3 TACTI-004 trial of eftilagimod alfa (LAG-3 MHC Class II agonist) + pembrolizumab + chemo regimen as a first-line treatment of NSCLC has been discontinued. Following a

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) +

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 Therapeut

17/12/2025 Incyte's Minjuvi® received the EC approval for treatment of R/R Follicular Lymphoma J&J's RYBREVANT FASPRO™ received the FDA approval for the treatment of EGFR-mutated NSCLC pharmaand GmbH's Rubraca received the FDA full approval for the treatment of BRCA mutant mCRPC Perioperative pembro + enfortumab vedotin elicited significant benefit in MIBC Incyte's Minjuvi® received the EC approval for treatment of R/R Follicular Lymphoma (Ref) The European Commission granted

16/12/2025 Adagene's muzastotug + pembro received the FDA fast track designation for MSS mCRC without current or active liver metastases Adagene's muzastotug + pembro received the FDA fast track designation for MSS mCRC without current or active liver metastases (Ref) The US FDA granted the fast track designation (FTD) to Adagene's muzastotug (ADG126; masked anti-CTLA-4) + pembrolizumab for the treatment of adult patients with microsatellite stable metastatic colorectal cance

01/12/2025 Cullinan Therapeutics' CLN-049 received the FDA fast track designation for R/R Acute Myeloid Leukemia Astellas Pharma and Pfizer's Type II variation application for perioperative enfortumab vedotin + pembro has been valiated by the EMA Cullinan Therapeutics' CLN-049 received the FDA fast track designation for R/R Acute Myeloid Leukemia (Ref) The US FDA granted the fast track designation to Cullinan Therapeutics' CLN-049 (FLT3 x CD3 bispecific T cell engager) for th

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 chemotherapy

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

08/10/2025 Regeneron's cemiplimab has been approved by the US FDA for the adjuvant Tx of CSCC (Ref) The US FDA approved Regeneron Pharmaceuticals' Libtayo® (cemiplimab; PD-1 inhibitor) as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation. The approval is based on results from the pivotal Phase 3 C-POST trial of adjuvant Libtayo vs placebo in patients with CSCC at high risk of recurrenc

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

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

04/09/2025 Eli Lilly and Company's olomorasib in combination with Keytruda received the FDA Breakthrough Therapy designation for metastatic KRAS G12C-mutant NSCLC (Ref) The US FDA granted the Breakthrough Therapy designation to Eli Lilly and Company's olomorasib (KRAS G12C inhibitor) + Merck & Co/MSD's pembrolizumab (anti-PD-1), for the first-line treatment of unresectable advanced or metastatic NSCLC with a KRAS G12C mutation and PD-L1 expression ≥ 50%. The designation was b