FDA "Poziotinib, Low Efficacy and Safety Concerns"... Hanmi Pharmaceutical "Patient Benefits Should Be Considered Against Risks" (Comprehensive)

Hanmi Aims for FDA Approval of Poziotinib Following Rollontis

Poziotinib FDA Advisory Committee Data Released
Serious Concerns Raised Over Efficacy and Safety
"If Approved, It Would Be the Least Effective Treatment"
Safety Issues: 85% Side Effects, 57% Dose Reduction

Hanmi: "Adverse Reactions Also Occur with Other Anticancer Drugs... Diverse Treatment Options Needed"

Exterior view of Hanmi Pharmaceutical headquarters

[Asia Economy Reporter Lee Chun-hee] Following the FDA approval of the new drug 'Rolontis' for neutropenia treatment, Hanmi Pharmaceutical's research and development (R&D) strategy aiming for back-to-back FDA new drug approvals with the anticipated approval of the non-small cell lung cancer treatment 'Poziotinib' within this year has hit a red light. The FDA raised strong doubts about the efficacy and safety of Poziotinib through its advisory committee, increasing concerns that approval may be difficult.

According to the FDA on the 21st, the FDA released related meeting materials ahead of the Oncology Drug Advisory Committee (ODAC) meeting scheduled to be held online from 9 a.m. on the 22nd (local time, 10 p.m. on the 22nd Korean time).

According to these materials, the advisory committee expressed strong concerns about Poziotinib's efficacy, stating, "If granted accelerated approval, this would be the least effective targeted therapy for lung cancer approved to date."

Portion of the briefing document by the U.S. Food and Drug Administration (FDA) mentioning the efficacy of Hanmi Pharmaceutical's non-small cell lung cancer treatment 'Poziotinib'

The advisory committee expressed concern that the objective response rate (ORR), which refers to the proportion of patients showing an objective response such as tumor size reduction among all patients, is low at around 28%. The committee directly mentioned the ORR of 58% for 'Enhertu' (generic name: trastuzumab deruxtecan), an antibody-drug conjugate (ADC) anticancer new drug by AstraZeneca-Daiichi Sankyo, which was recently approved in Korea. They also pointed out that the median duration of response (mDoR) for Poziotinib is 5.1 months, which is lower compared to Enhertu's 8.7 months.

The advisory committee also viewed the safety profile of Poziotinib as concerning due to side effects. Among 368 patients receiving a daily 16 mg dose of Poziotinib, 85% experienced grade 3-4 adverse events, and 57% required dose reductions, indicating low drug tolerance. While the committee noted that such side effects might be alleviated in alternative dosing groups, they emphasized the need for further analysis regarding the efficacy at this dosage.

Molecular structure image of Poziotinib

Following this news, there are growing forecasts that FDA approval of Poziotinib, with a decision deadline set for November 24, will be difficult. However, Hanmi Pharmaceutical explained that Poziotinib is a second- or third-line treatment rather than a first-line therapy, and considering the nature of anticancer drugs, side effects are likely to occur, so the risk-benefit balance must be taken into account.

A Hanmi Pharmaceutical representative stated, "The adverse reactions reported so far are cases that also appear with other drugs," emphasizing, "They can be sufficiently predicted and managed, and the benefits Poziotinib provides to patients clearly outweigh the risks." Regarding usefulness, they added, "Lung cancer has a much higher mortality rate compared to other cancer types, so various treatment options should be available to patients. Poziotinib can be administered as a second- or third-line treatment for patients who do not respond to existing therapies, and its oral formulation, rather than intravenous (IV) administration, offers convenience, making its usefulness clear."

They also stressed that the ODAC advisory content does not directly determine FDA approval. Hanmi Pharmaceutical said, "The recommendations following ODAC discussions are not binding on the FDA's final approval decision," and "The FDA will review all circumstances, including ODAC recommendations, and decide on final approval by November 24."

Meanwhile, after Rolontis cleared the FDA hurdle on the 10th, expectations for Poziotinib had risen, but the stock prices of Hanmi Pharmaceutical and its U.S. partner Spectrum Pharmaceuticals have turned red. Spectrum's stock closed at $0.66 on the 21st (local time), down 37.5% from the previous day's closing price. Hanmi Pharmaceutical's shares also traded around 238,000 KRW, nearly 15% lower than the previous day's closing price following this news.

This content was produced with the assistance of AI translation services.