Momelotinib

Incyte's Povorcitinib Shows Significant Efficacy in Phase 3 Trials for Hidradenitis Suppurativa

2 months ago

• Incyte's oral JAK1 inhibitor povorcitinib demonstrated statistically significant results in two Phase 3 trials (STOP-HS1 and STOP-HS2) for moderate to severe hidradenitis suppurativa, meeting primary endpoints at both 45mg and 75mg doses. • The drug showed particularly strong efficacy in patients previously exposed to biologics, with up to 45% achieving HiSCR50 response compared to 19.5% on placebo, addressing a critical unmet need in treatment-resistant cases. • With a favorable safety profile and rapid onset of action, povorcitinib could become the first oral targeted therapy for hidradenitis suppurativa, with regulatory submissions planned worldwide based on these positive results.

FDA Grants Broad Approval for GSK's Ojjaara in Myelofibrosis with Anemia

3 months ago

• GSK's JAK inhibitor Ojjaara (momelotinib) receives FDA approval for both newly diagnosed and previously treated myelofibrosis patients with anemia, surpassing expected second-line only indication. • The drug demonstrated significant benefits in the MOMENTUM trial, with 31% of patients achieving transfusion independence at week 24 compared to 20% in the control group. • Ojjaara addresses multiple disease manifestations including anemia, constitutional symptoms, and splenomegaly, offering a new treatment option where current therapies often worsen anemia.

Breakthrough Drug Omjjara Approved in Australia for Rare Bone Marrow Cancer Treatment

4 months ago

After three decades of research, Melbourne scientists have achieved a medical milestone with the approval of Omjjara, a once-daily pill for treating myelofibrosis, a rare bone marrow cancer. This groundbreaking treatment, also known as momelotinib, offers new hope for patients by significantly improving their quality of life and has already been approved in Europe and the US.

GSK Acquires IDRx for $1 Billion to Advance GIST Treatment

4 months ago

• GSK has agreed to acquire IDRx for $1 billion upfront, plus $150 million in potential milestone payments, to enhance its gastrointestinal cancer portfolio. • The acquisition brings IDRX-42, a selective KIT tyrosine kinase inhibitor, which targets key mutations in gastrointestinal stromal tumors (GIST). • IDRX-42 has shown promising anti-tumor activity in Phase I/Ib trials, particularly in patients with GIST who have developed resistance to existing therapies. • GSK aims to accelerate the development of IDRX-42 in 2025, potentially redefining the treatment landscape for GIST patients with limited options.

PharmaEssentia's Besremi Shows Phase III Success for Essential Thrombocytopenia

5 months ago

• PharmaEssentia reports positive Phase III trial results for Besremi in treating essential thrombocytopenia, a platelet disorder. • The company plans to seek label expansion for Besremi, which is already approved for polycythemia vera. • This expansion could provide a new treatment option for patients with essential thrombocytopenia, addressing an unmet medical need.

Novel Ruxolitinib Dosing Strategy Shows Promise in Managing Anemic Myelofibrosis Patients

5 months ago

• The REALISE trial demonstrates that a lower initial dose of ruxolitinib (10mg twice daily) in anemic myelofibrosis patients allows for better treatment tolerance while maintaining clinical efficacy. • Alternative dosing approach resulted in over 50% of patients achieving spleen responses and nearly 50% showing symptom improvements, while reducing transfusion dependencies over time. • Study findings suggest starting at lower doses with gradual escalation could help patients stay on treatment longer, potentially maximizing therapeutic benefits while minimizing hematologic adverse events.

Myelofibrosis Treatment Landscape Evolves with Novel Therapies and Combination Strategies

6 months ago

• Emerging therapies like luspatercept, nuvisertib, and pelabresib show promise in addressing myelofibrosis symptoms and anemia, potentially improving patient outcomes. • Combination strategies, particularly those involving JAK inhibitors with agents like pelabresib or navitoclax, aim to enhance spleen volume reduction and symptom control. • Research focuses on identifying biomarkers and refining endpoints to better assess disease modification and personalize treatment approaches for myelofibrosis patients. • Novel agents targeting calreticulin and hemojuvelin, along with advancements in JAK inhibitors, offer potential for more targeted and effective myelofibrosis therapies.

Health Canada Approves GSK's Ojjaara (momelotinib) for Myelofibrosis with Anemia

6 months ago

• Health Canada has approved GSK's Ojjaara (momelotinib) for treating myelofibrosis (MF) in adult patients with moderate-to-severe anemia. • The approval is based on Phase III MOMENTUM trial data, which showed improvements in symptom score, transfusion independence, and splenic response rate compared to danazol. • Ojjaara, a once-daily oral treatment, is indicated for intermediate or high-risk primary MF, post-polycythemia vera MF, or post-essential thrombocythemia MF. • This approval provides a new treatment option for Canadian patients with myelofibrosis-related anemia, addressing a critical unmet need in hematology oncology.

Drug Development Updates