Poziotinib’s Shift Of Focus To HER2 May Increase Approval Chances
Potential First-Line Therapy
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.
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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.
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