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Janssen Seeks Full Approval for Balversa in FGFR3-Altered Bladder Cancer

NEW YORK – Janssen said on Monday that it is seeking full approval in the US for Balversa (erdafitinib) as a treatment for patients with FGFR3-altered locally advanced or metastatic urothelial carcinoma after progressing on an anti-PD-1/PD-L1 therapy in the metastatic setting or within a year of neoadjuvant or adjuvant treatment.

The firm has submitted a supplemental new drug application to the US Food and Drug Administration seeking to convert the agency's earlier accelerated approval for the FGFR inhibitor. That April 2019 accelerated approval made Balversa available to bladder cancer patients who have progressed on at least one line of platinum-containing chemotherapy or progressed after one year of neoadjuvant or adjuvant chemo if they harbored FGFR3 or FGFR2 alterations in their tumors. The FDA also approved Qiagen's Therascreen FGFR RGQ RT-PCR Kit as a companion diagnostic to identify patients with these alterations who are eligible for Balversa treatment.

In a statement, a company spokesperson said that Janssen is "pursuing approval of Balversa for the treatment of patients with locally advanced or metastatic urothelial carcinoma which has susceptible FGFR3 genetic alterations. Data from more than 8,000 patients screened in the Phase III THOR study support this approach."

This suggests that Janssen is seeking full approval for Balversa in a more limited molecularly defined subset of patients, those with just FGFR3-altered tumors, compared to the accelerated approval indication, which included patients with FGFR2 and FGFR3 alterations. The THOR trial included patients with FGFR2 alterations, but the spokesperson did not answer a direct question about whether data from this trial was insufficient to confirm Balversa's benefit in this subgroup.

In seeking full approval, Janssen submitted confirmatory data from cohort 1 of the Phase III THOR trial comparing Balversa to standard-of-care chemotherapy in advanced, previously treated FGFR-altered bladder cancer patients. In June, researchers presented results from this cohort, showing that patients on Balversa had a median overall survival of about one year compared to 7.8 months on standard-of-care chemo. Treatment with Balversa also led to longer median progression-free survival, 5.6 months versus 2.7 months on chemo, and a higher response rate, 46 percent versus 12 percent, respectively.

Janssen will report at an upcoming medical meeting data from cohort 2 of the THOR trial, comparing Balversa against Merck's checkpoint inhibitor Keytruda (pembrolizumab) in patients who haven't received prior anti-PD-1/PD-L1 therapy.