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J&J’s targeted bladder cancer treatment gets US approval

Balversa is first FGFR inhibitor

J&J

Johnson & Johnson’s highly anticipated bladder cancer drug Balversa has been approved in the US, becoming the first personalised treatment targeting a certain type of genetic mutations.

The FDA authorised the once-daily drug to treat bladder cancer patients who carry Fibroblast growth factor (FGFR) alterations, genetic mutations that are present in approximately one in five patients with recurrent and refractory bladder cancer.

“We’re in an era of more personalised or precision medicine, and the ability to target cancer treatment to a patient’s specific genetic mutation or biomarker is becoming the standard, with advances being made in new disease types,” said Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

“FGFRs regulate important biological processes including cell growth and division during development and tissue repair. This drug works by targeting genetic alterations in FGFRs,” he explains.

The drug, which will only be used in those whose disease has progressed during or following prior platinum-containing chemotherapy, received a breakthrough designation from the FDA in September last year, which allowed the medicines regulator to more quickly assess Balversa.

J&J was awarded that status following the kinase inhibitor's data, which showed an overall response rate of 32.2%, with 2.3% having a complete response and almost 30% having a partial response.

The results were deemed as a breakthrough, as most patients that fall into that particular category of bladder cancer are normally unresponsive to immunotherapy and checkpoint inhibitors – the standard of care in bladder cancer.

"We recognise the significant unmet need that persists in the treatment of men and women diagnosed with this form of urothelial carcinoma, and we have worked expeditiously to develop Balversa for patients in close consultation with the FDA," said Peter Lebowitz, Global Therapeutic Area Head, Oncology, Janssen Research & Development.

"We look forward to the continued development of Balversa to understand how this important new therapy may further inform the care of patients with metastatic urothelial carcinoma and its investigational use in other cancers where FGFR alterations may be present in the future."

Despite the first-to-market personalised medicine claim for FGFR in bladder cancer, J&J could soon be joined by Incyte, which has its own oral FGFR inhibitor, Pemigatinib, in phase 2 testing for bladder cancer.

The company has confirmed it plans to release updated data from FIGHT-201 this year, which will support recruitment into the study. AstraZeneca also has an FGFR candidate in a phase 1b trial for bladder cancer.

Although FGFR inhibitors have been developed for use within bladder cancer, the drugs’ use could be extended into earlier-stage cancers, further expanding its potential in the market.

Incyte are also reviewing their candidate in advanced/metastatic or surgically unresectable bile duct cancer with fibroblast growth factor (FGF)/FGFR genetic alterations and expects to file an NDA later this year.

Article by
Gemma Jones

15th April 2019

From: Regulatory

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