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CHMP Updates - January'26
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

Oncofocus Team
Feb 91 min read


CHMP Updates - June'25
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

Oncofocus Team
Jun 24, 20252 min read


Oncology Updates - Key Oncology News
May 1st Week, 2025 Regulatory Events 🎯 Summit Therapeutics, Inc. and Akeso Biopharma’s ivonescimab (PD-1 x VEGF BsAb) mono has been approved in China for the 1L Tx of NSCLC with PD-L1 ≥1%. (Ref 1) ❓ When can we expect ivonescimab to receive the first approval in the key markets? 🎯 The UK’s MHRA approved Bristol Myers Squibb’s nivolumab (anti-PD-1) subcutaneous formulation for a broad range of cancers, including kidney, melanoma, lung, head and neck, bladder, colorectal,

Oncofocus Team
Jun 23, 20252 min read
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