Highlights from the CHMP June 2026 Meeting are out! New Biosimilar Medicines 💊 Ascend GmbH & Enzene Biosciences Ltd's denosumab (Denosumab Ascend; anti-RANKL) is intended for the prevention of bone complications in adults with advanced cancer involving bone and for the treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity Indication Expansions 💊 AstraZenec

Highlights from the CHMP Apr 2026 Meeting are out! New Generics 💊 Viatris' palbociclib (Palbociclib Viatris; CDK4/6 inhibitor) for the treatment of HR+ HER2- locally advanced or metastatic breast cancer either in in combination with an aromatase inhibitor, or in combination with fulvestrant in women who have received prior endocrine therapy Indication Expansions 💊 Otsuka Pharmaceutical Companies (U.S.)'s fixed‑dose oral combination of decitabine‑cedazuridine (Inaqovi; hypom

Highlights from the CHMP Mar 2026 Meeting are out! New Medicines 💊 Ferring Pharmaceuticals’ nadofaragene firadenovec gene therapy for the Tx of adults with BCG-unresponsive NMIBC with CIS with/without papillary tumours 💊 Amgen's tarlatamab (DLL3 x CD3 BsAb) for the Tx of adults with ES-SCLC, who require systemic therapy following disease progression on or after 1L Tx with platinum-based chemo 💊 PharmaMar & Jazz Pharmaceuticals' lurbinectedin (alkylating agent) + atezolizum

20/03/2026 BMS received approvals from US FDA and EC for Opdivo-based treatment combinations for classical Hodgkin Lymphoma BMS received approvals from US FDA and EC for Opdivo-based treatment combinations for classical Hodgkin Lymphoma (Ref) The US FDA approved Bristol Myers Squibb's nivolumab (anti-PD-1) + doxorubicin + vinblastine + dacarbazine for the treatment of adult and pediatric patients 12 years and older with previously untreated, Stage III or IV cHL. Additionally,

Highlights from the CHMP Feb 2026 Meeting are out! New Medicines 💊 Ipsen's tovorafenib (Ojemda; Type II RAF kinase inhibitor) is indicated as monotherapy for the treatment of patients 6 months of age and older with paediatric low‑grade glioma (LGG) harbouring a BRAF fusion or rearrangement, or BRAF V600 mutation, who have progressed after one or more prior systemic therapies New Biosimilars 💊 Henlius and Organon's pertuzumab (Poherdy; HER2/neu receptor antagonist), an inter

Bristol Myers Squibb's Q4 2025 earnings call spotlighted key milestones for the Opdualag franchise in melanoma 📊 Blockbuster Status and US Dominance Four years post-launch, Opdualag reached blockbuster status with 2025 global revenues of $1,185M, driven by $1,045M in the US. It has captured over 30% US market share, cementing its role as a standard-of-care option for metastatic melanoma. The ex-US market remains largely untapped with sales generating only $140M, constrained

Highlights from the CHMP Jan 2026 Meeting are out! Indication Expansions 💊 Johnson & Johnson Innovative Medicine's niraparib & abiraterone acetate co-formulation (Akeega; PARP x CYP17 inhibitor) is indicated with prednisone or prednisolone in combination with androgen deprivation therapy (ADT) for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) and BRCA 1/2 mutations (germline and/or somatic) 💊 Incyte and Takeda's ponatinib (Iclusig

07/01/2026 Arbele's ARB1002 received the FDA orphan drug designation for pancreatic cancer Curadel Pharma's CPI-008 imaging drug received the FDA and EMA orphan drug designation for pancreatic cancer Arbele's ARB1002 received the FDA orphan drug designation for pancreatic cancer (Ref) The US FDA granted the orphan drug designation to Arbele's ARB1002 (CDH17 targeting ADC) for the treatment of pancreatic cancer. Dr Linda Wu, CDO, Arbele: "Orphan Drug Designation for ARB1002 m

Highlights from the CHMP Dec 2025 Meeting are out! New Medicines 💊 Conditional marketing authorisation of ImmunityBio, Inc.'s nogapendekin alfa inbakicept (Anktiva: IL-15 superagonist complex) in combination with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours 💊 Jiangsu Hansoh Pharmaceutical Group Co., Ltd.’s aumolertinib (Aumseq

Highlights from the CHMP Nov 2025 Meeting are out! New Medicines 💊 Eli Lilly and Company's imlunestrant (Inluriyo: brain-penetrant oral ERα degrader) is indicated as monotherapy for the treatment of adult patients with ER+ve, HER2-ve, locally advanced or metastatic breast cancer with an activating ESR1-mutation, who have disease progression following prior treatment with an endocrine based regimen. New Hybrid Medicines 💊 Accord Healthcare's enzalutamide (Enzalutamide Accord

Highlights from the CHMP Oct 2025 Meeting are out! Indication Expansions 💊 Bristol Myers Squibb's lisocabtagene maraleucel (Breyanzi; autologous CD19-directed CAR T-cell therapy) is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor 💊 CStone Pharmaceuticals and Ewopharma's sugemalimab (Cejemly; anti-PD-L1) as monotherapy is indi

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

Highlights from the CHMP July 2025 Meeting are out! New Medicines 💊 Servier's vorasidenib (Voranigo; IDH1/2 inhibitor) monotherapy for the treatment of predominantly non-enhancing Grade 2 astrocytoma or oligodendroglioma with an IDH1 R132 or IDH2 R172 mutation in adult and adolescent patients aged 12 years and older and weighing at least 40 kg who only had surgical intervention and are not in immediate need of radiotherapy or chemotherapy New Biosimilars 💊 Henlius' denosuma

24/06/2025 Opdivo + Yervoy received supplemental approval in Japan to expand the use for unresectable hepatocellular carcinoma (Ref) Ono Pharmaceutical and Bristol-Myers Squibb K.K. have received a supplemental approval of Opdivo (nivolumab; anti-PD-1) + Yervoy (ipilimumab; anti-CTLA-4) in Japan, to expand the use for the treatment of unresectable hepatocellular carcinoma (HCC) The approval is based on the results from the global Phase 3 CheckMate-9DW trial of nivo + ipi vs i

Highlights from the CHMP June 2025 Meeting are out! New Medicines 💊 Cordex Biologics' (an ExCellThera company) dorocubicel (Zemcelpro; UM171 Cell Therapy) has been recommended for a conditional marketing authorisation for the treatment of adult patients with haematological malignancies requiring an allogeneic haematopoietic stem cell transplantation following myeloablative conditioning for whom no other type of suitable donor cells is available. Indication Expansions 💊 Exel

Highlights from the CHMP May 2025 Meeting are out! ⭐ New Medicines 💊 Autolus Therapeutics' obecabtagene autoleucel (Aucatzyl; CD19 CAR-T cell therapy) for the treatment of adults from 26 years of age with R/R B cell precursor acute lymphoblastic leukaemia 👉 Positive opinion recommending the granting of a conditional marketing authorisation 💊 GSK's belantamab mafodotin (Blenrep; anti-BCMA ADC) for the treatment of adults with R/R multiple myeloma: 👉In combination with bort

Highlights from the Committee for Medicinal Products for Human Use (CHMP) January 2025 Meeting are out! Here are the positive recommendations in the Oncology space (Ref 1): ⭐ New Therapies: 👉 AstraZeneca and Daiichi Sankyo's datopotamab deruxtecan (TROP2-directed ADC) for the treatment of adult patients with unresectable or metastatic HR-positive, HER2-negative breast cancer (post-endocrine therapy + chemo) 👉 Pfizer, Zai Lab, and Genmab's tisotumab vedotin (tissue factor-di

12/06/2025 MAIA Biotechnology and Roche announce a master clinical supply agreement for hard-to-treat cancer therapies (Ref) MAIA Biotechnology entered into a clinical master supply agreement with Roche for future trials evaluating MAIA’s ateganosine (THIO; telomere-targeting agent) in combination with Roche's atezolizumab (Tecentriq; anti-PD-L1) for the treatment of multiple hard-to-treat cancers. Ateganosine's highly synergistic and effective activity in combination with at