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J&J files ‘breakthrough’ bladder cancer drug in US

Needed as most patients don't respond to checkpoint inhibitors


Johnson & Johnson has filed for approval of a new targeted bladder cancer therapy in the US, setting up a possible approval next year.

The new drug candidate – selective fibroblast growth factor receptor inhibitor erdafitinib – is an oral, once daily treatment for the second-line treatment of patients with locally advanced or metastatic urothelial cancer (UC) with certain FGFR mutations whose tumours have progressed after chemotherapy. FGFR mutations typically occur in around one in five UC patients.

Erdafitinib (JNJ-42756493) picked up a breakthrough designation (BTD) from the FDA earlier this year, so should benefit from a rapid review by the regulator, setting up a possible approval in the first half of 2019. The application is based on data from a phase 2 trial (BLC2001) which was presented at this year’s American Society of Clinical Oncology (ASCO) meeting.

The study was listed among the best-in-show studies, mainly because despite the emergence of immunotherapy with checkpoint inhibitors – which has transformed the prospects for some bladder cancer patients in recent years – the majority of patients don’t respond to this type of treatment.

The 99-patient study revealed a 40% overall response rate with erdafitinib, 3% complete responses and 37% partial responses – along with a median progression-free survival of 5.5 months and median overall survival of 13.8 months.

Mathai Mammen

Mathai Mammen

Mathai Mammen, global head of Janssen R&D, said at an investor conference last week that the first indication for erdafitinib “will be a narrow but important use” and that the company’s plan is “to expand the application into many anatomic tumour types whose growth depends on mutations and translocations of the FGF receptor,” including bile duct cancer (cholangiocarcinoma).

J&J could face near-term competition in the oral FGFR inhibitor category from Incyte, whose pemigatinib candidate is in phase 2 testing for bladder cancer and myeloid/lymphoid cancers, and poised to start phase 3 for bile duct cancer. Data from mid-stage studies should be available next year, and Incyte has said it hopes to be first-to-market in the bile cancer setting.

Other companies active in this area include AstraZeneca with AZD4547, which is in a phase 1b trial in bladder cancer and mid-stage testing in breast and gastroesophageal tumours.

There are drugs already on the market for cancer that target FGFR non-selectively, but activity at other pathways affects their tolerability and limit their use.

Article by
Phil Taylor

20th September 2018

From: Marketing



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