Poziotinib’s Shift Of Focus To HER2 May Increase Approval Chances
Potential First-Line Therapy
Executive Summary
Encouraging new data for Spectrum/Hanmi’s poziotinib presented at ESMO may increase the chances of approval for the pan-HER inhibitor as a possible first-line therapy for NSCLC with the HER2 exon 20 insertion mutation, although the patient population is limited.
You may also be interested in...
US FDA Panel To Weigh Safety, Tolerability Issues For One New, Two Approved Cancer Drugs
Oncologic Drugs Advisory Committee will review Spectrum’s poziotinib for use in targeted subset of patients with previously treated non-small cell lung cancer; ODAC also will consider next steps for two approved drugs with adverse survival trends in postmarketing studies: Oncopeptides’ Pepaxto in multiple myeloma and Secura Bio’s Copiktra for CLL/SLL.
Finance Watch: SPACs Lose Their Luster As Difficulties Mount
Public Company Edition: While panelists at Biotech Showcase argued merging with a special purpose acquisition corporation is not as attractive as it used to be, firms continue to pursue this go-public alternative. Also, Hillstream launched a small IPO and Cytokinetics accessed cash from Royalty Pharma.
Keeping Track: Spectrum Submits Poziotinib; US FDA Approves Daré’s Xaciato, Expands Heron Zynrelef Label
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker