FDA Awards Fast Track Status to Treatment for HER2 Exon 20–Mutated NSCLC


The FDA has granted a fast track designation to poziotinib for use in previously treated non-small cell lung cancer patients with HER2 exon 20 mutations.

The FDA has granted a fast track designation to poziotinib for use in previously treated patients with HER2 exon 20 mutations, according to an announcement from Spectrum Pharmaceuticals.1 The submission of a new drug application (NDA) for the agent is anticipated later this year, according to Spectrum Pharmaceuticals.

“There are currently no approved therapies to treat patients with HER2 exon 20 mutations and we are pleased that the FDA has granted fast track designation for poziotinib,” Joe Turgeon, president and chief executive officer of Spectrum Pharmaceuticals, stated in a press release. “Momentum is building to unlock the potential of poziotinib.”

Recent data from cohort 3 of the phase 2 ZENITH20 trial (NCT03318939) were presented at the 2021 ESMO TAT Virtual Congress and showed that when poziotinib was given at a daily dose of 16 mg, it elicited clinically meaningful activity in treatment-naïve patients with metastatic NSCLC with EGFR exon 20 mutations.2 The objective response rate (ORR) achieved in this patient population was 27.8% (95% CI, 18.4%-39.1%) and the disease control rate (DCR) was 86.1%.

At a median follow-up of 9.2 months, 12 of 79 patients continued to receive poziotinib. The median duration of response (DOR) with the agent in this cohort was 6.5 months. Notably, 91% of patients in the intent-to-treat (ITT) population experienced tumor shrinkage with poziotinib.

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