Spectrum to push back launch date of Hanmi-developed drug Poziotinib

Hanmi Pharmaceutical Co. announced Friday that California-based Spectrum Pharmaceuticals Inc. received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA), which will delay a new drug’s release date. 

Hanmi had earlier conducted a technology transfer of the cancer drug Poziotinib to Spectrum. 

The FDA denied a request from the California pharmaceutical firm to allow it to release the new drug earlier than scheduled, based on the results of the second clinical trial. 

Poziotinib is a drug being developed by Hanmi, Luye Pharma and Spectrum for various cancers, especially lung cancer. The medicine, built on an anilino-quinazoline scaffold, inhibits the epidermal growth factor receptors EGFR, HER2/neu, and Her 4 and binds covalently to its targets. 

The CRL indicates that the FDA has conducted an in-depth review of the data in a Non-Disclosure Agreement (NDA), an Abbreviated New Drug Application (ANDA), or a Biologics License Application (BLA) submission and subsequently found that it cannot approve the application as it is. 

Each CRL specifies the reasons why the FDA found the submission inadequate and often includes recommendations on how the applicant can rectify the deficiencies. 

If and when Spectrum undertakes a third clinical trial and takes all the necessary steps, the launch of Poziotinib would be pushed back to 2025. 

Industry insiders say the FDA decision was widely expected. 

Write to Ji-Hyun Lee at bluesky@hankyung.com
Jee Abbey Lee edited this article.