Latest Keytruda Qlex nod shows ongoing complexity

Several subcutaneously delivered anti-PD-(L)1 antibodies have now been approved retrospectively for uses in which their IV forms are already available, but it’s not quite so simple for future approvals. That much emerged during Merck & Co’s fourth-quarter presentation, when this disclosed details of Keytruda’s newly sought indication of relapsed PD-L1-positive platinum-resistant ovarian cancer, backed by the Keynote-B96 study. Merck noted that the FDA had set two separate PDUFA dates for this: 20 February for IV Keytruda, and 14 April for the SC version, Keytruda Qlex. That might be a technicality – especially as in the event both were approved on the same day, 10 February – but it implies that separate filings have to be submitted, and reviewed, for each subsequent indication. This contrasts with Keytruda Qlex’s first approval, given broadly for “most” approved indications of the IV form, based on the Keynote-D77 trial. The one outlier, Merck told ApexOnco at the time, was periadjuvant head and neck cancer (Keynote-689), for which IV Keytruda was greenlit last June – after the Keytruda Qlex filing had been submitted, and as such not included in the subsequent SC approval. Keytruda Qlex was then approved for this use last October. 

This story has been updated.