Tag Archive for: blood cancer

A final analysis of Gilead Sciences’ now-discontinued Phase III ENHANCE study showed a worrying trend of increased death risk in myelodysplastic syndromes patients treated with magrolimab.

The company said patients with a type of leukemia who took its Scemblix had a significantly better response and a lower dropout rate than those who received current standard-of-care drugs in a late-stage study with details presented today.

The agency’s green light is a shot in the arm for ImmunityBio, which had reiterated doubts in a regulatory filing last month about its ability to remain in business.

An FDA advisory committee agreed that using minimal residual disease could be a viable surrogate endpoint for accelerated approval for drug development in multiple myeloma.

Today the agency allowed the use of Bristol-Myers Squibb (BMY.N) and 2seventybio’s cell therapy Abecma in less severely affected patients with a type of blood cancer.

Regeneron Pharmaceuticals said the U.S. FDA has declined approval for its blood cancer therapy for two forms of lymphoma, raising concerns over the progress of ongoing confirmatory trials.

Staff reviewers said that the pattern of early deaths observed in patients treated with both the therapies in their respective trials raised uncertainty about the treatments’ overall survival benefit in patients.

The injectable drug imetelstat was being studied in patients with lower risk myelodysplastic syndromes (MDS), a type of blood cancer, which requires frequent blood transfusions for managing anemia.

The company stated that Adcetris, extended survival in patients with the most common type of lymphoma in a late-stage study, bolstering efforts to expand the use of the treatment gained through its $43 billion purchase of Seagen.

A study showed GSK’s experimental drug Blenrep helped extend survival in patients with a type of blood cancer without symptoms worsening, marking a potential comeback for the drug after several setbacks.