TGA approves Roche’s cancer drug for precision medicine

Pharma News: The Therapeutic Goods Administration (TGA) approved Roche’s ROZLYTREK (entrectinib) for the treatment of adult patients with advanced ROS1-positive non-small cell lung cancer (NSCLC), and patients with NTRK fusion-positive (NTRK+) solid tumours.

ROZLYTREK delivers precision medicine as it targets a tumour’s biomarker instead of the type of tissue from which the tumour originated. A validated biomarker test is required and a ROS1-positive status should be established prior to initiation of Rozlytrek therapy in NSCLC.

ROZLYTREK’s solid tumours indication was approved via TGA’s provisional approval pathway, based on objective response rate and duration of response in single-arm trials. Full registration for this indication depends on verification and description of clinical benefit in confirmatory trials.

Register FREE & join 22,000+ industry professionals in reading the latest industry news & engaging content from Health Industry Hub, the ONLY one-stop-hub connecting Australia’s Pharma, MedTech and Biotech industry professionals.

In March 2020, the Pharmaceutical Benefits Advisory Committee (PBAC) recommended ROZLYTREK on the Pharmaceutical Benefits Scheme (PBS) for the treatment of advanced ROS1 fusion-positive non-small cell lung cancer. Before ROZLYTREK can be listed on the PBS for this indication, there are certain conditions and arrangements that need to be addressed. Roche is currently working through these steps in order to achieve the earliest possible patient access to ROZLYTREK.

Roche is also exploring the opportunity to pursue public funding of ROZLYTREK for the treatment of patients with NTRK+ solid tumours. There are particular challenges in the Australian reimbursement system relating to ‘tumour agnostic’ therapies (those approved to treat a range of tumour types, which share a common biomarker) and therapies for cancers that are driven by a rare biomarker. Medicines that require the use of a biomarker test (in this case, NTRK fusion testing) require a co-dependent submission to the PBAC and MSAC, and the approach needed to demonstrate cost-effectiveness in this case is complex and challenging.

In alignment with the Government’s mental health initiative the #SelfcareInHealthcare campaign has been launched to support Pharma, Biotech and MedTech industry professionals. The initiative is supported by Medicines Australia, AusBiotech and ARCS Australia. Learn more.

Roche is working with the Government, the research community, clinicians and health consumer organisations to help demonstrate the value of broader access to genomic testing for patients living with cancer. In the meantime, the company is recruiting eligible patients with NTRK+ solid tumours for treatment with ROZLYTREK at several clinical trial sites in Australia.