Myelodysplastic Syndromes

Nov 13, 2023

Servier’s Tibsovo (ivosidenib tablets) has received an expanded indication from the FDA, allowing its utilization in patients diagnosed with relapsed or refractory myelodysplastic syndromes that exhibit an IDH1 mutation. This new approval represents the fifth for Tibsovo, which is already recognized for its efficac...

Sep 15, 2023

The number of people diagnosed with myelodysplastic syndrome in the US each year is unknown. However, some estimates have put this number at about 10,000, while other estimates have been much higher. Moreover, myelodysplastic syndrome is uncommon before age 50, and the risk increases as a person gets older. It is a...

Jul 25, 2023

Gilead To Discontinue Phase III ENHANCE Study of Magrolimab Plus Azacitidine in Higher-Risk MDS Gilead Sciences, Inc. reported that the Phase III ENHANCE study in higher-risk myelodysplastic syndromes (MDS) has been halted due to futility based on a planned analysis. The safety data in this trial are consistent ...

Nov 01, 2022

Actinium Announces Positive Top-line Results from Pivotal Phase III SIERRA Trial of Iomab-B Actinium Pharma is on track to submit its targeted radiotherapy for AML patients requiring a bone marrow transplant in the United States, boosted by top-line data from a pivotal trial. The SIERRA trial of Iomab-B, an anti...

Apr 05, 2022

FDA Approves Yescarta as a First CAR T-cell Therapy for Initial Treatment of R/R Large B-cell Lymphoma Until now, existing CAR-T therapies have been reserved for patients with blood cancer who have tried multiple treatments. The FDA has approved Yescarta, a CD19-directed CAR-T therapy developed by Gilead Science...

Jan 14, 2022

The innovation in the oncology drug pipeline has resulted in a record number of FDA and EU approvals in recent years, as investigators and sponsors seek new and targeted treatments for individuals diagnosed with different types of cancers each year. In 2022, regulators will continue to evaluate new oncology therapi...

Dec 13, 2021

There has been limited progress in the approval of novel agents in MDS. It has been a long wait since the last approval of lenalidomide (Revlimid) – only approved for 5–10% (del 5q) MDS patients – was granted 13 years back. Since then, only two other companies, Celgene and Astex Pharma; could succeed in getting app...

Mar 03, 2020

Gilead Sciences has announced to purchase an Immuno-oncology company Forty Seven for USD 95.50 per share, totalling up to a deal value of USD 4.9 billion. By acquiring Forty Seven – named after its lead molecule - CD47 tumor cell protein - Gilead will acquire its lead candidate, Magrolimab, adding value to its ...