Posted on 2023-01-26 in Newsletter

FDA Grants Fast-Track Designation to Tamibarotene for Higher-Risk Myelodysplastic Syndrome Treatment

FDA Grants Fast-Track Designation to Tamibarotene for Higher-Risk Myelodysplastic Syndrome Treatment

FDA Grants Fast-Track Designation to Tamibarotene for Higher-Risk Myelodysplastic Syndrome Treatment

Syros Pharmaceuticals, Inc., a biopharmaceutical company focused on improving treatment for hematologic malignancies patients through innovative standards of care, announces United States FDA has granted Fast Track Designation for tamibarotene in higher-risk myelodysplastic syndrome (HR-MDS) treatment. Tamibarotene, a first-in-class oral RARα agonist, is being tested with azacitidine in RARA gene overexpression HR-MDS patients.

Publish Date: 26-01-2023   Source: Syros Pharmaceuticals, Inc.

Myelodysplastic syndromes (MDS) are a group of myeloid malignancies that result in dysplastic and ineffective hematopoiesis and have a poor 5-year relative survival estimate. The only curative treatment option for MDS is stem cell transplantation following high-dose chemotherapy and total body irradiation, which, given the toxicity of the treatment regimen, is typically reserved for younger, healthier patients. MDS in older patients or those without a suitable bone marrow donor is generally limited to supportive care with transfusions, hematopoietic growth factors, or chemotherapy.

  • The incidence of MDS patients identified as eligible for 2nd -line therapy was 3/100,000. Approximately 9,500 people per year in the United States may be candidates for 2nd -line therapy for MDS.
  • The risk of MDS increases with advancing age; approximately 86% of patients with newly diagnosed MDS in the United States are 60 years old (median age, 76 years).

However, the current Myelodysplastic Syndromes (MDS) treatment market share, market uptake, and attribute analysis concerning the most potential emerging therapies (Imetelstat, AG-946, ACE-536, etc.) has been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, UK) Japan and China.

In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for the Myelodysplastic Syndromes (MDS) treatment. The key companies in the advanced development stage are Geron Corporation, Agios Pharmaceuticals, Inc., Acceleron Pharma Inc, etc., targeting MDS.

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook forecast report on Myelodysplastic Syndromes (MDS) to provide a clear understanding of disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2021 to 2032.

About Thelansis:

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Competitive intelligence and track of trial results throughout the phases of development executed by a team of a mix of Scientific and Business backgrounds. As an organization, the primary focus is to provide real-world data evidence and market insight to pharmaceutical companies for their decision-making.

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