Hanmi Pharm shares down on FDA panel's disapproval of fast-tracking poziotinib

[Photo by Hanmi Pharmaceutical]

Hanmi Pharmaceutical shares weakened on Friday on negative developments in the U.S. over its investigational non-small cell lung cancer (NSCLC) drug poziotinib, which was licensed out to U.S. partner Spectrum Pharmaceuticals.

Spectrum announced on Thursday that the U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) voted 9-4 that the current benefits of the drug did not outweigh its risks.

Shares of Hanmi were 0.8 percent lower at 237,500 won ($168) at 1:00 p.m. Friday.

Poziotinib has been tested for the treatment of patients with previously treated locally advanced or metastatic NSCLC harboring HER2 exon 20 insertion mutations.

ODAC is an independent panel of experts that reviews and evaluates efficacy and safety data of investigational cancer drugs. The committee makes recommendations to the FDA, but the recommendations are not binding and the final decision on product approval will be made solely by the FDA.

The FDA will review all the opinions from experts and make a final approval decision by November 24 according to the Prescription Drug User Fee Act (PDUFA).

“We are disappointed by the outcome of the ODAC meeting, as patients with NSCLC HER2 exon 20 insertion mutations are in need of additional effective and safe therapies. We plan to carefully evaluate our options for this program as we approach the PDUFA date,” said Tom Riga, president and CEO of Spectrum Pharmaceuticals, in a statement.

The ODAC recommendation followed an unfavorable statement from the FDA’s scientist session where the majority said poziotinib may not provide a meaningful advantage over available therapies and additional analyses will be required. The scientists said the data provided shows a low 28 percent overall response rate (ORR) and the safety profile is poor.

Spectrum and Hanmi immediately refuted the statement, saying the drug is an innovative treatment that can serve well as one of many treatment options for patients with no other cure.

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