Daily Newsletter

11 September 2023

Daily Newsletter

11 September 2023

Janssen seeks EMA authorisation for urothelial cancer treatment

In the Phase III THOR study, study subjects in the erdafitinib arm had a median OS of more than one year.

Vishnu Priyan September 11 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson has filed a marketing authorisation application (MAA) with the European Medicines Agency for erdafitinib to treat locally advanced unresectable or metastatic urothelial carcinoma (UC).

The company is seeking approval to use the therapy to treat adult UC patients with susceptible fibroblast growth factor receptor 3 (FGFR3) genetic mutations. 

These patients should have advanced on or after receiving a minimum of one line of therapy comprising a programmed death receptor-1 or programmed death-ligand 1 inhibitor to be eligible to receive the treatment.

A once-a-day oral inhibitor of pan-fibroblast growth factor receptor (FGFR) tyrosine kinase, erdafitinib is being analysed in Phase II and III clinical trials in advanced UC patients.

The latest application is based on findings from cohort 1 of the Phase III THOR clinical trial assessing the safety and efficacy of erdafitinib compared with chemotherapy.

The trial met the primary endpoint of overall survival (OS), with study subjects in the erdafitinib arm demonstrating a median OS of more than one year at an interim analysis.

Janssen Research & Development solid tumours clinical development vice-president Kiran Patel said: “Erdafitinib has demonstrated promising results in advanced, FGFR-altered UC, making this submission a vital step towards improving outcomes for patients in the future. 

“The OS benefit we have seen with erdafitinib also supports the need for biomarker testing for FGFR alterations in all patients with metastatic UC.”

The US Food and Drug Administration (FDA) granted accelerated approval for erdafitinib in April 2019 for locally advanced or mUC treatment.

In August 2023, the company filed a supplemental new drug application with the regulator seeking full approval of the therapy based on data from the Phase III THOR study.

The FDA also approved Janssen’s Akeega for metastatic castration-resistant prostate cancer treatment.

Significant opportunities and risks for disease-modifying therapies (DMTs) entering the PD market

As PD therapy currently centers on symptomatic treatment, the need for DMTs is one of the greatest unmet needs. Several companies within the late-stage PD pipeline are developing drugs that target PD via novel MOAs. KOLs remain hopeful that these companies will uncover a class of drugs that works effectively to slow or modify the disease course. Targeting α-synuclein and other neurotoxic proteins is a key strategy in the late-stage pipeline for DMTs.

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