FDA Expands Asciminib Indication, Concerns Arise Over Accelerated Approvals
Key Insights
The FDA has expanded the indications for asciminib (Scemblix) through accelerated approval for adults with newly diagnosed Philadelphia chromosome (search)-positive chronic myeloid leukemia (search).
Recent market withdrawals of drugs approved via the FDA's accelerated approval pathway have sparked concerns regarding the robustness of the approval process.
A phase II/III trial of uproleselan plus cytarabine/daunorubicin in acute myeloid leukemia (search) failed to meet its primary endpoint of event-free survival.
The FDA has expanded the indications for asciminib (Scemblix), granting accelerated approval for its use in adult patients newly diagnosed with Philadelphia chromosome (search)-positive chronic myeloid leukemia (search) (CML) in the chronic phase. This decision aims to provide a new treatment option for patients with this specific type of leukemia.
Accelerated Approval Pathway Under Scrutiny
However, the accelerated approval pathway itself is facing increased scrutiny. Multiple recent market withdrawals of drugs initially approved through this route have raised concerns about the reliability and long-term efficacy of drugs approved via this mechanism. BioSpace reports that these withdrawals have led to a broader debate about the standards and evidence required for accelerated approvals.
Uproleselan Trial Fails to Meet Endpoint
In other news, GlycoMimetics (search) announced that a phase II/III trial of uproleselan in combination with cytarabine and daunorubicin for newly diagnosed acute myeloid leukemia (search) (AML) did not meet its primary endpoint of event-free survival. This outcome represents a setback in the development of new treatments for AML, a particularly aggressive form of leukemia. The trial was conducted by the National Cancer Institute.
Metformin's Anticancer Activity Questioned
Separately, emerging evidence is prompting a closer look at the purported anticancer activity of metformin, a widely prescribed drug for type 2 diabetes. Oncology News Central reports that recent findings have cast doubt on metformin's potential benefits in cancer prevention or treatment, challenging previous hopes regarding its role in oncology.