Ahead of an adcomm meeting for Spectrum Pharmaceutical IncSPPI, FDA released briefing documents related to poziotinib for treating patients with previously treated locally advanced or metastatic NSCLC harboring HER2 exon 20 insertion mutations.
FDA’s Oncologic Drugs Advisory Committee (ODAC) is scheduled to meet on September 22, Thursday.
In a briefing document, the FDA scientists state that the data provided shows a low overall response rate (ORR) with a minimal duration of response. ORR was 28%, while the median DOR was 5.1 months.
In addition, they noted a poorly tolerated safety profile at the currently proposed dosage (16 mg QD), with 57% of patients experiencing dose reductions and 85% of patients experiencing grade 3-4 adverse events.
The rate of interruptions and dose reductions may be mitigated in patients receiving alternative dosages.
Also, the FDA team faults Spectrum’s inadequate dosage optimization since the company has proposed two different doses for accelerated approval and the planned confirmatory trial. “Confirmation of benefit will be significantly delayed given that confirmatory trial has not begun enrolling patients.”
The document raised concerns regarding the totality of evidence supporting the application. The significant delay in confirming the benefit of a randomized clinical trial heightens the uncertainty around the risk-benefit assessment.
The confirmatory trial has not enrolled any patients to date and is not expected to report top-line results for 4-5 years.
Price Action: SPPI shares are down 25.50% at $0.79 on the last check Tuesday.
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