Oncology Updates - Key Oncology News

Oncofocus Team
5 days ago
2 min read

April 2nd Week, 2025

Regulatory Events

🎯AstraZeneca and Daiichi Sankyo’s trastuzumab deruxtecan (HER2 ADC) mono has been approved in the EU for the Tx of unresectable/metastatic HR+ve, HER2-low/ultralow breast cancer patients who have received at least one endocrine Tx in the metastatic setting and who are not suitable for endocrine Tx as the next line of Tx. (Ref 1)

❓What is the status of trastuzumab deruxtecan for these patients in other key markets?

🎯AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan (TROP2 ADC) mono has been approved in the EU for the Tx of unresectable/metastatic HR+ve, HER2-ve breast cancer patients who have received endocrine Tx and at least one line of chemo in the advanced setting. (Ref 2)

❓Does datopotamab deruxtecan's data package enable it to be positioned as the go-to Tx option in this patient population?

🎯Johnson & Johnson’s amivantamab (EGFR x MET BsAb) subcutaneous + lazertinib has been approved in the EU for the first-line Tx of advanced NSCLC with EGFR ex19del or ex21 L858R mutations, and as a mono for advanced NSCLC with EGFR ex20 insertion mutations after failure of platinum-based Tx. (Ref 3)

❓What are the pros and cons of the subcutaneous formulation, and how will they impact the market uptake of the regimen?

🎯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, MSI-H/dMMR colorectal cancer. (Ref 4)

❓What are the outcomes of nivolumab + ipilimumab that supported the approval?

🎯Bayer’s larotrectinib (TRK inhibitor) has been granted full approval by the US FDA for the Tx of unresectable/metastatic solid tumor patients who have a NTRK gene fusion without a known acquired resistance mutation and have no satisfactory alternative Tx or have progressed following Tx. (Ref 5)

❓What are the other regimens in pipeline targeting this patient population which may pose competitive threat to larotrectinib?

Market Access

🚀Germany’s Federal Joint Committee (G-BA) granted “Considerable” added benefit status to MSD's pembrolizumab (anti-PD-1) + Astellas Pharma and Pfizer’s enfortumab vedotin (Nectin-4 ADC) for cisplatin-ineligible urothelial cancer. However, the G-BA concluded that the combo offered a "non-quantifiable" additional benefit in cisplatin-eligible patients. (Ref 6)