Hanmi Pharmaceutical’s clinical development program of its investigational non-small cell lung cancer (NSCLC) drug poziotinib has hit a snag due to unfavorable opinions from the U.S. Food and Drug Administration (FDA) scientists ahead of an Oncologic Drugs Advisory Committee (ODAC) meeting.

In a briefing document for its scientist session on Wednesday, the FDA said poziotinib may not provide a meaningful advantage over available therapies and additional analyses will be required.

Poziotinib is an oral tyrosine kinase inhibitor to treat patients with previously treated locally advanced or metastatic NSCLC harboring the human epidermal growth factor receptor exon 20 insertion mutation. The drug was licensed out to U.S. Spectrum which is seeking an FDA approval.

The FDA scientists said the data provided shows a low 28 percent overall response rate (ORR) and the safety profile is poor as 85 percent of patients had grade 3-4 adverse events.

Spectrum and Hanmi immediately refuted the statement, saying it should be noted that this drug provides a new option for patients for whom there is no cure today.

The adverse events of poziotinib are predictable and manageable, and the benefits clearly outweigh the risks, said a Hanmi official, stressing the drug’s usefulness as an orally taken second or third-line treatment for patients who do not respond to existing treatments.

Hanmi and Spectrum plan to highlight the drug’s clinical usefulness at the ODAC meeting to draw a positive recommendation. But the ODAC’s recommendation does not guarantee the FDA’s approval. The FDA’s final decision will come out by Nov. 24.

By Pulse

[ⓒ Pulse by Maeil Business Newspaper & mk.co.kr, All rights reserved]