厄达替尼的安全性和有效性

It is an oral pan-FGFR inhibitor. FGFRs are a family of receptor tyrosine kinases, and genetic mutations that appear in different tumors can cause them to be activated, thereby promoting the survival and proliferation of tumor cells.

On April 12, 2019, the U.S. FDA granted accelerated approval to the oral small molecule pan-FGFR inhibitor Erdafitinib (trade name: Balversa) from Janssen, a subsidiary of Johnson & Johnson, for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who carry FGFR2/3 mutations or fusions and have disease progression during or after platinum-based chemotherapy (including within one year of neoadjuvant chemotherapy or adjuvant chemotherapy).

Is erdafitinib safe and effective?

The BLC2001 study is a multicenter, open-label phase II study designed to evaluate the efficacy and safety of erdafitinib in the treatment of FGFR-mutated locally advanced or metastatic urothelial carcinoma. The results showed that 99 patients received a median of 5 cycles of erdafitinib treatment. Among them, 43% of patients had received at least 2 courses of treatment in the past, and 79% had visceral metastasis. After treatment, the confirmed objective response rate (ORR) was 40% (3% complete response and 37% partial response). Among 22 patients who had previously received immunotherapy, the confirmed ORR was 59%. The median progression-free survival (PFS) was 5.5 months, and the median overall survival (OS) was 13.8 months. Patients with FGFR mutations have poor response to immunotherapy, and targeted drugs should be preferred.

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.

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