Regulatory FDA Gives Green Light to GSK's Innovative Bone Cancer...

FDA Gives Green Light to GSK’s Innovative Bone Cancer Drug, Validating Billion-Dollar Investment


The Food and Drug Administration (FDA) has granted approval for GSK’s groundbreaking treatment for myelofibrosis, a form of bone marrow cancer, signifying a significant milestone in the pharmaceutical industry. The newly approved medication, scientifically known as momelotinib, is set to revolutionize the treatment landscape for this rare disease, challenging the existing therapies offered by Incyte and Bristol Myers Squibb.

Myelofibrosis is a relatively uncommon cancer characterized by the development of scarring in the bone marrow, often leading to severe anemia and a host of other debilitating health issues. Momelotinib, now FDA-approved, is the sole medication sanctioned by the agency to address the primary manifestations of myelofibrosis in patients, both newly diagnosed and previously treated, who suffer from anemia.

GSK, which acquired momelotinib through its purchase of Sierra Oncology for nearly $2 billion last year, intends to market the drug under the name Ojjaara. GSK expresses confidence in Ojjaara’s “substantial growth potential,” though some industry analysts have raised questions about its potential impact compared to rival therapies from Incyte and Bristol Myers Squibb. GSK’s acquisition of Sierra underscores its belief in Ojjaara as a superior treatment option in the myelofibrosis market.

Currently, Incyte’s Jakafi and Bristol Myers’ recently approved Inrebic have been available for several years. Clinical trials have shown that both drugs can alleviate myelofibrosis symptoms. However, they sometimes worsen anemia, a critical concern for patients dealing with severe anemia-related symptoms such as fatigue, weakness, and shortness of breath, often requiring frequent blood transfusions or stem cell transplants.

Ojjaara operates similarly to Jakafi and Inrebic by targeting Janus kinases (JAKs), which play crucial roles in various bodily functions, including cell growth regulation and immune system activity.

In contrast, Ojjaara, while sharing a similar mechanism with Jakafi and Inrebic by targeting Janus kinases (JAKs), also inhibits ACVR1, a multifunctional protein found in bone tissue. GSK believes that this ACVR1 inhibition is responsible for Ojjaara’s effectiveness in managing anemia.

In a pivotal late-phase clinical trial, a significantly larger portion of individuals with myelofibrosis who were administered Ojjaara experienced a noteworthy reduction of 50% or more in symptoms linked to the disease when compared to those undergoing older treatment regimens. Furthermore, Ojjaara demonstrated favorable impacts on various health markers, including the reduction in spleen size and the reduced necessity for blood transfusions.

Initially, the FDA had scheduled the evaluation of Ojjaara’s approval application for August 2022, with an expected decision date of June 16. Nevertheless, the FDA opted to extend the approval deadline by three months to thoroughly evaluate additional data that the company had submitted. Although GSK did not provide specific details about the nature of this supplementary data, some analysts in the financial sector conjectured that it could potentially support the drug’s broader utilization if it received approval. Notably, the FDA granted clearance for Ojjaara’s usage in myelofibrosis patients afflicted with anemia, regardless of their prior treatment history.

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