Tamibarotene

Syros Receives Fast Track Designation from the FDA for Tamibarotene for the Treatment of Newly Diagnosed Unfit AML with RARA gene overexpression

Retrieved on: 
Tuesday, April 9, 2024
Biotechnology, FDA, Health, Pharmaceutical, Clinical Trials, Toxicity, Aplastic anemia, Syros, Tamibarotene, AML, Patient, Fast Track, Venetoclax, Acute myeloid leukemia, Azacitidine, Prognosis, MDS, Bone marrow, RARA, Pharmaceutical industry

Tamibarotene, an oral first-in-class selective retinoic acid receptor alpha (RARα) agonist, is currently being evaluated in combination with venetoclax and azacitidine for the treatment of newly diagnosed AML patients with RARA gene overexpression.

Key Points: 
  • Tamibarotene, an oral first-in-class selective retinoic acid receptor alpha (RARα) agonist, is currently being evaluated in combination with venetoclax and azacitidine for the treatment of newly diagnosed AML patients with RARA gene overexpression.
  • “We are pleased to receive Fast Track designation for tamibarotene for the treatment of AML.
  • Syros is evaluating tamibarotene in combination with venetoclax and azacitidine in newly diagnosed, unfit AML patients with RARA overexpression in the ongoing SELECT-AML-1 Phase 2 trial.
  • In January 2023, the FDA granted Fast Track Designation to tamibarotene for the treatment of HR-MDS patients with RARA overexpression.

Syros Receives Fast Track Designation from the FDA for Tamibarotene for the Treatment of Higher-Risk Myelodysplastic Syndrome

Retrieved on: 
Thursday, January 26, 2023
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, RARA, AML, Patient, Bone marrow, Azacitidine, Tamibarotene, Syros, Disease, Venetoclax, Fast Track, SELECT, Medication, Pharmaceutical industry

Syros Pharmaceuticals, Inc. (NASDAQ:SYRS), a biopharmaceutical company committed to advancing new standards of care for the frontline treatment of hematologic malignancies, today announced that the United States Food and Drug Administration (FDA) has granted Fast Track Designation to tamibarotene for the treatment of higher-risk myelodysplastic syndrome (HR-MDS).

Key Points: 
  • Syros Pharmaceuticals, Inc. (NASDAQ:SYRS), a biopharmaceutical company committed to advancing new standards of care for the frontline treatment of hematologic malignancies, today announced that the United States Food and Drug Administration (FDA) has granted Fast Track Designation to tamibarotene for the treatment of higher-risk myelodysplastic syndrome (HR-MDS).
  • “Receipt of Fast Track designation for tamibarotene underscores both the potential of tamibarotene and the unmet need for HR-MDS patients, who have a poor prognosis due to the progressive nature of the disease,” said David A. Roth, M.D., Chief Medical Officer of Syros Pharmaceuticals.
  • A therapeutic candidate that receives Fast Track designation may be eligible for more frequent interactions with the FDA to discuss the therapeutic candidate’s development plan.
  • Therapeutic candidates with Fast Track designation may also be eligible for priority review and accelerated approval if supported by clinical data.

Syros Pharmaceuticals Announces Publication in Blood Advances Demonstrating the Potential of Tamibarotene in Patients with RARA Gene Overexpression, Supporting Ongoing Clinical Development in AML and MDS

Retrieved on: 
Monday, December 12, 2022
Oncology, Health, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, Genome, Security (finance), ORR, Observation, Freedom, Azacitidine, Venetoclax, Institut Gustave Roussy, Patient, CR, Toxicity, Tamibarotene, Annual report, Compte rendu, Biology, Aplastic anemia, Arsenic trioxide, Myelodysplastic syndrome, Government, COVID-19, AML, Clinical trial, Safety, CDK7, Workforce, MDS, Acute myeloid leukemia, Gene, AES, RARA, Acute promyelocytic leukemia, Pharmaceutical industry, Syros

These findings support Syros ongoing evaluation of tamibarotene for the treatment of AML and myelodysplastic syndrome (MDS) patients with RARA overexpression.

Key Points: 
  • These findings support Syros ongoing evaluation of tamibarotene for the treatment of AML and myelodysplastic syndrome (MDS) patients with RARA overexpression.
  • The biomarker test successfully identified AML patients positive for RARA overexpression who were enriched for response to tamibarotene and azacitidine relative to those patients who were negative for RARA overexpression.
  • This observation further demonstrates that the activity of tamibarotene is dependent on the biology of RARA overexpression.
  • Based on RARA expression levels, each patient was classified as positive for RARA overexpression (22 patients) or negative for RARA overexpression (29 patients).