The acceptance by the FDA is based on the positive data from a Phase II study in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) treated earlier harboring HER2 exon 20 insertion mutations.
At present, the FDA has not specifically approved any treatment for this indication.
Spectrum Pharmaceuticals president and CEO Tom Riga said: “The NDA acceptance is a major step toward advancing the treatment for patients with HER2 exon 20 insertion mutations in lung cancer.
“This remains an area of high unmet medical need as there are no treatments specifically approved for these patients. We are actively working with the agency to support the review process.”
The company’s poziotinib has received Fast Track designation.
The FDA, which has set a Prescription Drug User Fee Act (PDUFA) date of 24 November 2022, reiterated the importance of having the confirmatory trial substantially enrolled during approval.
It also requested the company additional information related to dosing and currently has no plans to conduct an advisory committee meeting for the application.
In the Cohort 2 of Phase II ZENITH20 study, 90 patients received a once daily oral dose of 16mg of poziotinib.
In the intent-to-treat analysis, a confirmed objective response rate (ORR) of 27.8% (95% Confidence Interval (CI), 18.9%-38.2%) was observed.
The 18.9% observed lower bound exceeded the 17% pre-specified lower bound.
The median duration of response and the median progression free survival in the trial were 5.1 months and 5.5 months, respectively.