The TGA website has been updated to include a number of new originator applications for the months of July and August 2024.
The following expanded indications are being sought for MSD’s Keytruda® and BMS’s Opdivo®:
- BMS’s Opdivo® (nivolumab) for the treatment of patients with unresectable or metastatic colorectal cancer;
- MSD’s Keytruda® (pembrolizumab) for the treatment of recurrent locally advanced or metastatic Merkel cell carcinoma; and
- MSD’s Keytruda® (rch) in 100mg/4 mL concentrated injection vial for the treatment of unresectable advanced or metastatic malignant pleural mesothelioma.
As previously reported, the agenda for the September PBAC Intracycle Meeting includes an item providing for “initial guidance on parameters that need to be considered for future broad PBS listing proposals for PD-(L)1 inhibitors, and to advise on next steps to seek broader stakeholder input”. This agenda item is a multi-brand initiative that likely stems from efforts by MSD and BMS to secure expanded listings for Keytruda® (pembrolizumab) and Opdivo® (nivolumab) respectively.
Other applications currently under evaluation by the TGA are:
- BMS’s Yervoy® (ipilimumab) in combination with nivolumab for the treatment of patients with unresectable or metastatic colorectal cancer;
- BeiGene’s Tevimbra® (tislelizumab) for the treatment of recurrent or metastatic nasopharyngeal carcinoma;
- Amgen’s Imdelltra® (tarlatamab) for the treatment of adult patients with advanced small cell lung cancer;
- Novartis’ Ilaris® (canakinumab) for the treatment of several autoinflammatory Periodic Fever Syndromes; and
- Accelagen’s Briumvi® (ublituximab) for the treatment of relapsing forms of multiple sclerosis.