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Oncology Updates - Key Oncology News
November 4th Week, 2025 Regulatory Events 🎯 The EC granted approval to Bristol Myers Squibb's lisocabtagene maraleucel (anti-CD19 CAR-T) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy including a BTK inhibitor. (Ref 1) ❓ How is this approval expected to impact the treatment algorithm of the indication? 🎯 The US FDA granted approval to AstraZeneca’s neoadjuvant durvalumab (anti-PD-L1) + chemot

Oncofocus Team
Dec 2, 20252 min read
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Oncology Updates - Key Oncology News
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

Oncofocus Team
Jun 23, 20252 min read
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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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