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Oncology Updates - Key Oncology News
March 4th Week, 2025 Regulatory Events đŻ CStone Pharmaceuticals submitted a Type II variation application to the EMA for sugemalimab (Cejelmy; anti-PD-L1) to treat stage III NSCLC patients who have not progressed following concurrent or sequential platinum-based CRT. (Ref 1) â How do sugemalimabâs outcomes compare with those of previously approved AstraZenecaâs durvalumab? Special Designations â Shandong Boan Biotechnology's BA1302 (a first-in-class CD228-directed ADC) has

Oncofocus Team
Jun 23, 20252 min read
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Oncology Updates - Key Oncology News
March 2nd Week, 2025 Mergers & Acquisitions đ¤ Checkpoint Therapeutics Inc is set to be acquired by SUN PHARMA, an Indian pharma giant. This deal will strengthen Sun Pharmaâs onco-dermatology portfolio, as it includes Unloxcyt (cosibelimab-ipdl), an FDA-approved anti-PD-L1 treatment indicated for advanced cutaneous squamous cell carcinoma (cSCC) (Ref 1) â How will this acquisition position Sun Pharma in the immuno-oncology space? What is the indication expansion strategy for

Oncofocus Team
Jun 23, 20252 min read
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Oncology Updates - Key Oncology News
March 1st Week, 2025 Regulatory Events đŻ Bristol Myers Squibbâ nivolumab (anti-PD-1) + ipilimumab (anti-CTLA-4) has been approved by the EC as a first-line Tx for unresectable or advanced HCC. (Ref 1) â How do the outcomes of nivolumab + ipilimumab compare against the previously approved Tx options for the first-line HCC? đŻ Johnson & Johnson's amivantamab (EGFR x MET BsAb) + lazertinib (EGFR TKI) has been approved by the UK's MHRA for EGFR mutant, metastatic NSCLC. (Ref 2)

Oncofocus Team
Jun 23, 20252 min read
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Oncology Updates - Key Oncology News
February 3rd Week, 2025 đWith the Ph3 CHECKMATE-816 trial meeting its key secondary endpoint of OS, BMSâ nivo + platinum-doublet CT became the first neoadjuvant-only Tx to significantly improve OS in resectable NSCLC patients. (Ref 1) âWill the positive OS data support BMSâ regimen in tackling the competitive threat from the perioperative chemo-IO regimens? đThe US FDA will be assessing BI's NDA of zongertinib (irreversible ERBB2 TKI) for previously treated, HER2+ve, unres

Oncofocus Team
Jun 23, 20252 min read
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