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Oncology Updates - Key Oncology News
August 1st Week, 2026 Regulatory Events 🎯 The US FDA granted an accelerated approval to Replimune's vusolimogene oderparepvec-wtpg (TUDRIQEVTM/RP1; oncolytic viral therapy) + Bristol Myers Squibb and Ono Pharma's nivolumab (Opdivo; anti-PD-1) for the Tx of adults with unresectable advanced cutaneous melanoma with disease progression on prior anti-PD-1 based regimen (Ref) ❓ How is this approval expected to impact the ≥2L Melanoma Tx paradigm? 🎯 Dr. Reddy's Laboratories ri

Oncofocus Team
Aug 131 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


Oncology Updates - Key Oncology News
April 3rd Week, 2025 Regulatory Events 🎯 Bristol Myers Squibb’s nivolumab (anti-PD-1) + ipilimumab (anti-CTLA-4) has been approved by the US FDA as a first-line Tx of unresectable/metastatic hepatocellular carcinoma. (Ref 1) ❓ What portion of the first-line HCC patients are anticipated to transition to the nivolumab + ipilimumab regimen? 🎯 ImmunityBio, Inc. completed the sBLA submission to the US FDA for nogapendekin alfa inbakicept (IL-15 superagonist fusion protein) + B

Oncofocus Team
Jun 23, 20252 min read
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