Professor Howard Gurney

The TGA has extended use of pembrolizumab (Keytruda) to include locally advanced or metastatic urothelial cancer in patients either not eligible for cisplatin-containing therapies or those who have previously received platinum-containing chemotherapy.

As reported previously in the limbic here, KEYNOTE-045 found an overall survival benefit in patients treated with pembrolizumab compared to second line chemotherapy such as paclitaxel, docetaxel or vinflunine.

The approval of pembrolizumab as a first line therapy is based on the results of the Keynote-052 study. The checkpoint inhibitor may be a suitable option for older patients who cannot receive cisplatin-based therapies due to impaired renal function.

Professor Howard Gurney, Director of Medical Oncology and Clinical Research at Macquarie University Hospital, said in a statement the approval represented ‘an important new treatment paradigm’ for patients with bladder cancer.

The five-year survival rate of 53% for bladder cancer reflects the historic lack of treatment advances in this patient group.

Pembrolizumab is now approved in Australia for bladder cancer, head and neck cancer, classical Hodgkin lymphoma, non-small cell lung cancer and melanoma but only PBS listed for melanoma.