Balversa (erdafitinib) has received complete approval from the FDA, permitting its use in the treatment of locally advanced or metastatic urothelial carcinoma in individuals with FGFR3 genetic alterations who have undergone at least one prior therapy. In a recent announcement regarding the updated label for the drug, the FDA emphasized that Balversa should not be administered to patients who are eligible for, but have not yet received prior PD-1/L1 therapy.
In comparison to its 2019 accelerated approval, Balversa’s complete approval brings two notable restrictions. Originally, it covered patients with FGFR2 alterations and targeted post-chemo patients, regardless of PD-1/L1 therapy eligibility.
A positive shift in the updated approval extends coverage to second-line patients, irrespective of prior systemic therapy, breaking away from the earlier limitation to platinum-based chemotherapy recipients. This broader approach allows patients progressing on standard PD-1 treatment to access Balversa.
Johnson & Johnson strategically focused on gaining full approval for patients with FGFR3 alterations, supported by the phase 3 THOR study (Study BLC3001). In cohort 1, Balversa demonstrated a 36% reduction in the risk of death compared to chemotherapy in previously treated patients, including those treated with a PD-1/L1 inhibitor.
The trial’s initial intent to include both FGFR2 and FGFR3 alterations, the absence of FGFR2 representation emphasize the rarity of this disease subtype, as explained by a J&J spokesperson.
Recent FDA trends highlight the exclusion of patient subgroups in approvals due to low representation in clinical trials or inconclusive efficacy data. In June 2023, patients with high-grade B-cell lymphoma were excluded in an approval for Roche’s large B-cell lymphoma therapy Columvi.
The details of Balversa’s approval process shed light on the FDA’s scrutiny of patient subgroup data and overall survival findings. Challenges arose in Cohort 2 of the THOR trial, where Balversa faced off against Keytruda, failing to outperform the latter in extending patients’ lives and being linked to an 18% increased risk of death.
The FDA’s comprehensive approval of Balversa (erdafitinib) includes specific modifications, allowing its use in addressing locally advanced or metastatic urothelial carcinoma in patients with susceptible FGFR3 genetic alterations after at least one prior therapy. Notably, the FDA caution against Balversa use in patients eligible for but not having received prior PD-1/L1 therapy.
Despite challenges, Johnson & Johnson remains optimistic, positioning Balversa as a viable option for patients needing treatment after PD-1/L1 inhibitor progression.
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