Early promise comes back to haunt Spectrum


Under normal circumstances a company would not even bother to announce that the US FDA had declined to award it breakthrough therapy designation. But if, like Spectrum Pharmaceuticals, you have already promised investors that this accolade had been applied for then you are obligated to disclose the result of such a move. This explains Spectrum’s post-market announcement yesterday, concerning the EGFR inhibitor poziotinib, and the company’s resulting 35% crash this morning. Ironically, it was the lack of breakthrough designation for this project that had put pressure on the group’s share price, causing it to confirm earlier this year that it had made an application, and that poziotinib “met the criteria” for this. Moreover, it is not entirely clear how much good breakthrough designation would have done Spectrum in the use applied for, EGFR-mutated metastatic NSCLC. The space is controlled by Astrazeneca, and is already fiercely competitive.

NSCLC therapy landscape for selected small-molecule targeted treatments
  Line of therapy/mutation  
Drug (company) 1st line 2nd line Note
Tarceva (Roche) EGFR+ EGFR+ Approved broadly, but EGFR testing is advised
Iressa (Astrazeneca) EGFR+   Exon 19 deletion or exon 21 substitution
Gilotrif (Boehringer Ingelheim) EGFR+   Broad EGFR+ label
Tagrisso (Astrazeneca) EGFR+ T790M+ T790M+ use is post EGFR TKI therapy
Vizimpro (Pfizer) EGFR+   Exon 19 deletion or exon 21 substitution
Poziotinib (Spectrum) EGFR+   Exon 20 mutation
Tepotinib (Merck KGaA)   c-Met+ Post EGFR TKI therapy
Capmatinib (Incyte)   c-Met+ Post EGFR TKI therapy
Savolitinib (Chi-Med/Astrazeneca)   c-Met+ Post EGFR TKI therapy
BLU-667 (Blueprint)   Ret+ Post EGFR TKI therapy
LOXO-292 (Loxo)   Ret+ Post EGFR TKI therapy

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