GSK announces extension of FDA’s review for momelotinib

Betsy Goodfellow | June 20, 2023 | News story | Medical Communications FDA, GSK, Oncology, momelotinib, new drug application 

GSK has announced that the US Food and Drug Administration (FDA) has extended its review period for the new drug application (NDA) for momelotinib by three months allowing it additional time to assess the recently submitted data. The extended action date is now 16 September 2023.

The drug was added to GSK’s portfolio, following the acquisition of Sierra Oncology. Particularly, momelotinib complements GSK’s new drug, Blenrep/belantamab mafatotin, which was approved for fourth-line multiple myeloma in 2020.

Momelotinib is intended to treat myelofibrosis patients with anaemia, and has a novel mechanism of action and inhibitory ability along three key signaling pathways; Janus kinase (JAK) 1, JAK2 and activin A receptor, type 1 (ACVR1). Inhibition of JAK1 and JAK2 could improve constitutional symptoms and splenomegaly, while inhibition of ACVR1 decreases circulating hepcidin which is elevated in myelofibrosis and contributes to anaemia.

The initial NDA was based on results from various key phase 3 trials including the MOMENTUM trial, which met all primary and key secondary endpoints, including Total Symptom Score (TSS), Transfusion Independence (TI) rate and Splenic Response Rate (SRR).

Affecting more than 25,000 patients in the US, myelofibrosis is a rare blood cancer resulting from dysregulated JAK-signal transducer and activator of transcription protein signalling. It is characterised by constitutional symptoms, splenomegaly and progressive anaemia.

Currently, momelotinib is not approved in any markets.

Betsy Goodfellow

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