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September 16, 2022

Australia TGA approves Specialised Therapeutics bile duct cancer therapy

The regulatory authority approved Pemazyre based on data from the Phase II FIGHT-202 trial.

The Australian Therapeutic Goods Administration (TGA) has granted provisional approval for Specialised Therapeutics’ targeted therapy, Pemazyre (pemigatinib), for the treatment of cholangiocarcinoma, a rare bile duct cancer.

The therapy is indicated for locally advanced or metastatic cholangiocarcinoma in adults who have a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that has advanced following a minimum of one previous line of systemic therapy.

Currently, the therapy is not reimbursed in Australia and will be offered to eligible patients through a co-pay access programme.

The regulatory authority approved Pemazyre for this indication based on data from the Phase II FIGHT-202 clinical trial.

The trial assessed the efficacy and safety of Pemazyre in adult patients.

According to data from the initial assessment of 108 subjects, Pemazyre offered a 37% objective response rate.

Additionally, 3.7% and 33.3% of the subjects had confirmed complete response and partial response, respectively. 

Pemazyre was also found to be well tolerated in the safety analysis, which included 147 subjects.

A kinase inhibitor, Pemazyre acts by hindering the abnormal FGFR2 protein in bile duct tumour cells, thereby averting the growth of such cells.

Incyte developed Pemazyre and is collaborating with Specialised Therapeutics to market the therapy in New Zealand, Singapore and Australia.

Specialised Therapeutics CEO Carlo Montagner said that Pemazyre was a ‘wonderful inclusion’ to the company’s portfolio of rare cancer therapies.

Montagner continued: “We look forward to providing this new highly-targeted treatment to eligible patients with cholangiocarcinoma who have limited therapy options.”

The approval in Australia comes after Pemazyre received similar approvals in the US, Europe, Canada, Japan and Great Britain.

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