The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) recently issued an approval for BALVERSA (erdafitinib) to treat adults with inoperable or spreading urothelial carcinoma (UC). The UK’s approval specifically includes UC that is harboring FGFR genetic mutations which can cause cancer cells to develop, grow, and spread.
Compared to chemotherapy, erdafitinib is an oral FGFR kinase inhibitor that extends overall survival. The FGFR gene is perhaps the most common genetic occurrence found in bladder cancer. Each year about 10,500 individuals in the UK are told that they have the disease with about 20% of that cohort having FGFR3 mutations.
A New Option
The MHRA approval presents a novel option after patients have undergone one or more lines of therapy with a PD-1 or PD-L1 inhibitor. By approving erdafitinib, an oral kinase inhibitor, the MHRA has provided treatment for patients who have bladder cancer that is in an advanced stage and have tumors that harbor FGFR3 mutations.
Needless to say, the erdafitinib authorization will be greatly appreciated by eligible patients.
Study Results
The Phase 3 THOR study served as the basis for the MHRA’s decision. The THOR study found that erdafitinib patients survived overall 12.1 months. This compares favorably against 7.8 months for patients treated with chemotherapy. The study also found an improvement in progression free survival such as 5.6 months compared to 2.7 months for chemotherapy.
J&J intends to begin immediately and expedite production of erdafitinib for patients with bladder cancer that has advanced or is at risk of advancing.
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bladder cancer news treatment urothelial carcinoma
Last modified: November 15, 2024
