J&J Secures Full FDA Approval for Bladder Cancer Drug Balversa
22 Jan 2024
Clinical ResultPhase 3Drug ApprovalPhase 2Accelerated Approval
Pictured: J&J's business center in Switzerland/iStock, yuelan
Johnson & Johnson announced on Friday that the FDA has granted its FGFR kinase inhibitor Balversa (erdafitinib) full approval for the treatment of locally advanced or metastatic urothelial carcinoma.
Friday’s full approval amends Balversa’s previous indication, which allowed its use in patients with susceptible mutations on the FGFR3 or FGFR2 genes, after platinum-based chemotherapy, according to the FDA’s announcement of the approval.
J&J’s pill is now indicated for patients with susceptible genetic alterations on the FGFR3 gene—as determined by an approved test—with disease progression after at least one prior line of systemic therapy. Balversa is not approved to treat patients who are eligible for, but have not yet undergone, PD-1 or PD-L1 inhibitor therapies.
Designed to be taken orally once-daily, Balversa is a small molecule FGFR kinase inhibitor that works by targeting and binding to FGFR1, FGFR2, FGFR3 and FGFR4, blocking their enzymatic activity, according to J&J’s website. This mechanism of action cuts off several signaling cascades and suppresses the uncontrolled division and survival of cancer cells.
Balversa won the FDA’s accelerated approval in April 2019 for certain types of locally advanced or metastatic urothelial carcinoma (mUC), becoming the first FDA-authorized FGFR inhibitor. At the time, Balversa was backed by findings from a small single-arm Phase II trial with 87 enrolled patients, demonstrating a 32.2% objective response rate and a median duration of response of 5.4 months.
To keep Balversa on the market, J&J ran the confirmatory Phase III THOR trial, which enrolled nearly 630 patients and compared the oral FGFR kinase inhibitor against the standard of care regimen, consisting of chemotherapy or Merck’s Keytruda (pembrolizumab). Patients who had undergone at least one prior line of anti-PD-(L)1 therapy were assigned to Cohort 1 of THOR, while those who had not were placed in Cohort 2.
Data from Cohort 1, which ultimately became the basis for the FDA’s full approval on Friday, showed that Balversa cut the risk of death by 36% versus chemotherapy. Patients in the Balversa arm also lived a median of four months longer than those on chemotherapy, an effect that was statistically significant, according to J&J’s announcement.
Kiran Patel, vice president of clinical development, solid tumors at J&J Innovative Medicine, said in a statement that “Balversa continues to demonstrate the promise of targeted therapy in the treatment of cancer with advanced bladder cancer,” given its performance in THOR.
Friday’s full approval for Balversa continues J&J’s winning streak in cancer. In December 2023, the pharma posted promising data from the Phase III PERSEUS study showing that a Darzalex Faspro-based quadruplet regimen could significantly improve progression-free survival in newly diagnosed multiple myeloma patients.
In October 2023, J&J’s head-to-head MARIPOSA study showed that the combination of Rybrevant and lazertinib could potentially best AstraZeneca’s Tagrisso (osimertinib) in EGFR-mutated non-small cell lung cancer.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
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