Spectrum Pharmaceuticals, Hanmi Pharmaceutical’s U.S. partner, said on Friday that it received a Complete Response Letter (CRL) from the FDA stating that the regulator needs supplementary data to approve poziotinib, a lung cancer treatment.

Hanmi Pharmaceutical’s U.S. partner, Spectrum Pharmaceuticals, received a Complete Response Letter (CRL) from the U.S. FDA on Thursday. 
Hanmi Pharmaceutical’s U.S. partner, Spectrum Pharmaceuticals, received a Complete Response Letter (CRL) from the U.S. FDA on Thursday. 

As the FDA notification coincides with the Thanksgiving holiday in the U.S., the official announcement with specific details of the CRL decision will be made by Spectrum on Friday evening (KST).

However, Hanmi decided to first disclose the receipt of the CRL in order to eliminate unnecessary misunderstandings regarding the timing of the disclosure, and will later inform domestic media when Spectrum announces its official position and future plans, said a Hanmi official.

Poziotinib aims to treat non-small cell lung cancer (NSCLC) with locally advanced and metastatic HER2 Exon 20 insertion mutation, for which there is currently no suitable treatment. 

Hanmi licensed out the treatment to Spectrum in 2019 and since then Spectrum applied for marketing authorization with the FDA on Dec. 6, 2021.

Earlier, the FDA Oncology Drug Advisory Committee voted nine to four against pozitonib on Sept. 23 regarding the drug’s expedited approval, citing that poziotinib’s current benefits did not outweigh the risks.

Regarding this earlier statement, an official from Hanmi Pharmaceutical said, "The FDA's decision was in accordance with the recommendation of the anti-cancer drug advisory committee at the time."

As of 11:18 am on Friday, Hanmi’s shares stood at 252,500 won ($189.87), down 1.94 percent from the previous trading day.

 

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