FDA Pushes Review Time For GSK's Blood Cancer Therapy Added Via Sierra Oncology Acquisition

The FDA has extended the review period for GSK plc's GSK new drug application for momelotinib for myelofibrosis by three months to provide time to review recently submitted data. 

The extended action date is 16 September 2023 compared to the earlier date of 16 June.

GSK is confident in the momelotinib NDA and looks forward to working with the FDA as they finalize their review.

The FDA accepted the momelotinib application in August last year based on the results from key phase 3 trials, including the pivotal MOMENTUM trial, which met all primary and key secondary endpoints, including Total Symptom Score (TSS), Transfusion Independence (TI) rate and Splenic Response Rate (SRR). 

GSK added the blood cancer therapy by acquiring Sierra Oncology Inc for $55 per share in cash, representing an approximate total equity value of $1.9 billion (£1.5 billion).

Myelofibrosis is a rare blood cancer that results from dysregulated JAK-signal transducer and activator of transcription protein signaling and is characterized by constitutional symptoms, splenomegaly, and progressive anemia. Myelofibrosis affects approximately 25,000 patients in the U.S. 

Momelotinib is not currently approved in any market.

Price Action: GSK shares are up 0.77% at $35.54 during the premarket session on the last check Friday.