MHRA Approves Johnson & Johnson’s Drug for Advanced Bladder Cancer Patients
In a significant step forward for bladder cancer treatment, Johnson & Johnson announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved BALVERSA (erdafitinib).
This innovative, oral medication is now available for adults with unresectable or metastatic urothelial carcinoma (UC) carrying specific FGFR3 genetic alterations, providing new hope for patients who have already received at least one round of treatment with a PD-1 or PD-L1 inhibitor.
Bladder cancer impacts about 10,500 individuals in the UK each year, with an estimated 20% of these cases driven by FGFR3 genetic alterations.
The treatment landscape for advanced bladder cancer has been notably limited, and a Professor of Lancashire Teaching Hospitals NHS Foundation Trust highlighted that patients with this advanced stage of bladder cancer, whose tumours harbour FGFR3 alterations, require access to innovative precision therapies.
What’s more, they went on to express that the authorisation of erdafitinib will be welcome news for eligible patients.
As an FGFR kinase inhibitor, erdafitinib directly targets the genetic characteristics of certain bladder cancers, and its impact has been underscored by the results of the Phase 3 THOR study.
The study revealed that patients treated with erdafitinib experienced a median overall survival of 12.1 months, compared to 7.8 months with chemotherapy. Additionally, progression-free survival was significantly improved, with a median of 5.6 months versus 2.7 months on chemotherapy.
The approval reflects Johnson & Johnson’s commitment to advancing cancer treatment through precision medicine. The Country Medical Director at Johnson & Johnson Innovative Medicine UK expressed enthusiasm for this milestone, noting that it underscores their dedication to getting ahead of cancer and delivering innovative therapies to patients in need.
Furthermore, Johnson & Johnson is already working with health authorities to make erdafitinib available through the NHS as soon as possible.
To conclude, with MHRA’s approval of BALVERSA, Johnson & Johnson is setting a new standard in treatment options for advanced bladder cancer, offering a therapy that targets specific genetic characteristics and extends survival for patients with limited alternatives.
As the company strives to bring erdafitinib to the NHS, eligible patients can look forward to a promising new option in their fight against this challenging disease.
News Credits: MHRA grants approval for bladder cancer drug erdafitinib
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