FDA panel votes against Spectrum’s lung cancer drug candidate licensed out by Hanmi

Spectrum Pharmaceuticals, Hanmi Pharmaceutical’s U.S. partner, said the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted nine to four against poziotinib, a lung cancer drug candidate, saying benefits of the drug did not outweigh risks.

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.

"It's clearly evident that it wasn't an easy decision for most of us," Medpage Today quoted the ODAC chair Jorge Garcia, a professor at Case Western Reserve University and University Hospitals in Cleveland, as saying on Thursday. "For those who voted yes, it does appear that relates to the efficacy of these agents in a patient population that is in need of active therapies and they were not too worried about the tolerability of this agent, based on prior experience and years of practice.”

He stressed that those who voted no said poziotinib’s efficacy was too marginal, compared to existing agents.

The FDA panel also judged that poziotinib had dose optimization issues.

In response to the ODAC’s decision, Spectrum CEO and President Tom Riga said the company was disappointed by the outcome because patients with NSCLC HER2 exon 20 insertion mutations were in need of additional effective and safe therapies.

“We plan to carefully evaluate our options for this program as we approach Nov. 24, 2022, which is when the FDA needs to decide on whether to approve the drug,” Riga said.

ODAC is an independent panel of experts that reviews and evaluates data concerning the efficacy and safety of marketed and investigational products for use in the treatment of cancer.

The panel makes appropriate recommendations to the FDA, but these recommendations are not binding and the final decision regarding product approval will be made solely by the FDA.

“There are cases where ODAC gave a negative opinion but the drug received FDA approval, while there are also cases where ODAC gave a positive opinion but the FDA did not approve the drug,” a Hanmi official said to Korea Biomedical Review. “We expect that the FDA will make a final approval by Nov. 24 after reviewing all circumstances, including the ODAC recommendation."

The news did not affect the stock price of Hanmi Pharmaceutical on Friday morning.

As of 9:40 a.m. on Friday, Hanmi’s shares stood at 236,500 won ($166.17), down 1.25 percent from the previous trading day.