dm+d

Unassigned

New Medicines

BalversaFGFR-positive solid tumours in adult and children patients who have progressed on or after at least 1 line of systemic therapy and have no satisfactory alternative treatments

Information

Balversa
New molecular entity
Janssen
Johnson & Johnson

Development and Regulatory status

Phase II Clinical Trials
Phase II Clinical Trials
Phase II Clinical Trials

Category

Pan-fibroblast growth factor receptor (FGFR) inhibitor
Variable depending on tumour type
FGFR-positive solid tumours in adult and children patients who have progressed on or after at least 1 line of systemic therapy and have no satisfactory alternative treatments
Oral

Further information

Yes

Evidence based evaluations

BalversaMetastatic or surgically unresectable urothelial cancer, FGFR mutation-positive

Information

Balversa
Licence extension / variation
Janssen
Johnson & Johnson

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Launched
Apr 19Launched in US [7].
Apr 19Approved by FDA for the treatment of adults with locally advanced or metastatic urothelial carcinoma [6].
Sep 18Filed in US [4].
Dec 17Regulatory filings in the US and the EU are anticipated between 2017 to 2021 (Janssen Phamaceutical pipeline, Oct 2017).
Dec 16Regulatory filings in the US and the EU are anticipated between 2016 to 2019 (Janssen Phamaceutica pipeline, July 2016).

Category

Pan-fibroblast growth factor receptor (FGFR) inhibitor
UK incidence of bladder cancer is 11.4 per 100,000 population. The vast majority of bladder cancers in the UK are transitional cell carcinomas (also known as urothelial cell carcinomas). The recurrence rate for superficial transitional cell cancer of the bladder is high (70% within five years). As many as 80% of pts have at least one recurrence [2].
Metastatic or surgically unresectable urothelial cancer, FGFR mutation-positive
Oral

Further information

Yes

Trial or other data

Dec 21Recruitment continues in PIII study (NCT03390504); collection of primary outcome data now expected to complete Apr 24 [10].
Oct 20PIII study (NCT03390504) continues to recruit [9].
Dec 19PIII study (NCT03390504) is recruiting; collection of primary outcome data proceeding as planned [8].
Mar 18PIII study to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after 1 or 2 prior treatments, at least 1 of which includes an anti-PD-(L) 1 agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2) starts (NCT03390504). 631 adults will be recruited from countries including the US, EU & UK. Collection of primary outcome data (overall survival) is due to complete Nov 20 [5].
Mar 18PII clinical trial (BLC2001) evaluating the efficacy and safety of erdafitinib in locally advanced or metastatic urothelial cancer, whose tumors have certain fibroblast growth factor receptor (FGFR) genetic alterations reported at ASCO 2018. Overall response rate was 42 percent in 59 patients with relapsed/refractory metastatic urothelial cancer[3].
Apr 15Janssen initiates an open-label PII trial to assess efficacy and safety of two dose regimens of erdafitinib in patients with urothelial cancer (NCT02365597; EudraCT2014-002408-26). Primary outcome is percentage of participants with best overall response at one year. The trial is enrolling approximately 165 patients in the US, Austria, Belgium, Spain, France, Germany, South Korea, Moldova, Romania, Russia, Taiwan and the UK [1].

Evidence based evaluations