杨森制药的厄达替尼用途和疗效

(Erdafitinib) is the first targeted inhibitor approved by the US FDA on April 12, 2019, for the treatment of locally advanced and metastatic bladder cancer in adult patients. The approval of erdafitinib represents the first personalized treatment for patients with metastatic bladder cancer who have predisposing FGFR gene alterations. Its development company, Janssen Pharmaceuticals, is one of the earliest joint ventures established in China and one of the first pioneers to devote itself to the development of the western region.

A multicenter, open-label, single-arm study, BLC2001 (NC-T02365597), evaluated the efficacy and safety of erdafitinib in patients with locally advanced or metastatic UC. A total of 87 patients were included in the study. The median age of the patients was 67 years old. All of these patients had received chemotherapy before. 97% of the patients had received at least one cisplatin or carboplatin chemotherapy, 56% of the patients had only received cisplatin-based treatment regimens, 29% had only received carboplatin-based treatment regimens, and 10% had received cisplatin and carboplatin treatment regimens. 24% of patients received anti-PD-L1/PD-1 therapy. These patients have disease progression during or after at least one chemotherapy episode and have specific FGFR3 gene mutations (R248C, S249C, G370C, Y373C) or FGFR gene fusions.

The starting dose for patients is 8 mg once daily. For patients with serum phosphorus levels <5.5 mg/dL, the dose can be increased to 9 mg once daily until disease progression or intolerable toxicity occurs. The primary efficacy endpoints were objective response rate (ORR) and duration of response (DOR).

The study results showed that the overall ORR and median duration of the efficacy population of 87 patients were compared with patients with FGFR3 fusion and FGFR2 fusion. Patients with FGFR3 mutations had a higher response and an acceptable safety profile.

Recommended hot articles: /newsDetail/96472.html

Note: The above information comes from the Internet and is compiled and edited by Medical Companion Travel (please correct me if there are any errors or omissions). It is only to provide information on the latest drugs on the market in the world and help Chinese patients understand the latest international new drug trends. It is only for internal discussion among medical staff and does not serve as any basis for medication. For specific medication guidelines, please consult the attending physician.