Spectrum Pharma announced Wednesday after the close that the FDA declined to accord Breakthrough Therapy Designation, or BTD, for poziotinib, its pipeline candidate that is being evaluated in the ZENITH20 study in patients with metastatic non-small cell lung cancer and EGFR exon 20 tumor mutations.
Now that the BTD designation is being denied, the existing development plan and timeline for a NDA filing based on the first cohort of the ZENITH20 trial still holds, the company said.
The BTD application was supported by data from 30 patients evaluated in the MD Anderson Phase 2 trial who had failed platinum-based chemotherapy.
Why It's Important
BTD is a FDA program that is meant to expedite the development as well as review of drugs that are meant to treat serious conditions where preliminary clinical evidence points to substantial superiority of the drug over an available therapy.
BTD accords privileges such as all Fast Track designation features and intensive guidance on efficient drug development beginning as early as Phase 1, as well as organizational commitment involving senior managers.
Spectrum Pharma said data needed for a NDA filing would come from an 87-patient cohort in the ZENITH20 study.
The company expects to complete enrollment in the cohort in the first quarter of 2019, with top-line data expected in the second half of the year.
"We will continue to work with the FDA to achieve the fastest route to approval of poziotinib based on our ZENITH20 study," Spectrum CEO Joe Turgeon said in a statement.
Spectrum Pharma shares were down 27.87 percent at $7.53 at the time of publication Thursday.
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