Pleasant Surprise For GSK: FDA Approves Bone Marrow Cancer Therapy Acquired Via Sierra Oncology Deal

FDA has approved GSK plc's GSK Ojjaara (momelotinib) for the treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis (post-polycythemia vera and post-essential thrombocythaemia), in adults with anemia. 

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).

To date, it is the only approved medicine for newly diagnosed and previously treated myelofibrosis patients with anemia that addresses the key manifestations of the disease, namely anemia, constitutional symptoms, and splenomegaly (enlarged spleen).

Myelofibrosis is a blood cancer affecting approximately 25,000 patients in the U.S.

Myelofibrosis can lead to severely low blood counts, including anemia and thrombocytopenia; constitutional symptoms such as fatigue, night sweats, and bone pain; and splenomegaly. 

The move comes as a pleasant surprise when, on Friday, the European Medicines Agency's human medicines committee recommended not renewing the conditional marketing authorization for Blenrep (belantamab mafodotin) for multiple myeloma.

Blenrep is a monotherapy treatment for adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies.

EMA's CHMP noted a study that found that patients who received Blenrep did not live longer without their disease worsening than those who received pomalidomide plus dexamethasone.

Last November, GSK initiated the withdrawal process of the U.S. marketing authorization for Blenrep after a failed DREAMM-3 Phase 3 confirmatory trial, which did not meet the requirements of the FDA Accelerated Approval regulations. 

Price Action: GSK shares are up 1.23% at $37.89 during the premarket session on the last check Monday.