FDA grants accelerated approval to Zenocutuzumab-zbco – The Babak Lab
The Babak Lab shared a post on LinkedIn:
“FDA Grants Accelerated Approval to Zenocutuzumab-zbco (Bizengri).
On December 4th, 2024, the FDA granted accelerated approval to zenocutuzumab-zbco (Bizengri, Merus N.V.), marking a significant milestone for patients with NRG1 fusion-positive cancers. NRG1 gene fusions are rare but actionable drivers of cancer growth.
Until now, there were no approved therapies targeting this specific genetic alteration. This is the first FDA-approved systemic therapy specifically for:
- Advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC) with NRG1 gene fusion, and
- Advanced, unresectable, or metastatic pancreatic adenocarcinoma with NRG1 gene fusion.
Both indications are for patients who have experienced disease progression following prior systemic therapy.
Key Efficacy Data from the eNRGy Study:
The approval was based on results from the eNRGy study (NCT02912949), which evaluated 64 NSCLC and 30 pancreatic adenocarcinoma patients with NRG1 fusions:
- NSCLC: Confirmed overall response rate (ORR) of 33%, with a median duration of response (DOR) of 7.4 months.
- Pancreatic Adenocarcinoma: Confirmed ORR of 40%, with DOR ranging from 3.7 to 16.6 months.
For more details, click the following link.
Let’s celebrate this advancement and continue pushing the boundaries of cancer care!”
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