27 April 2020 - How often does a PBAC outcome precede FDA approval?

At its March 2020 meeting, the PBAC recommended the addition of a flat 400 mg six weekly dosing regimen to the existing flat 200 mg three weekly dosing regimen for all existing and recommended PBS listings for pembrolizumab for melanoma and non-small cell lung cancer indications where pembrolizumab is used as monotherapy.

The PBAC noted that no clinical data comparing the 400 mg six weekly dosing regimen to the 200 mg three weekly dosing regimen was provided. However, based on the pharmacokinetic modelling data evaluated by the TGA, the PBAC considered that the effectiveness and safety of the two flat dosing regimens would likely be comparable.

A flat six weekly dosage regimen is yet to approved by the US FDA.

Just last week (23 April), Merck/MSD announced the resubmission of its supplemental biologics license applications to the U.S. FDA to update the dosing frequency for Keytruda, to include a 400 mg dose infused over 30 minutes every six weeks, in addition to the currently approved dose of 200 mg every three weeks. 

Applications were filed across all adult indications for Keytruda, including use as monotherapy and in combination. 

Merck/MSD filed the resubmissions to address the FDA's complete response letter that was issued in February 2020.