Boryung Zepzelca, conditional approval with phase 2 data

It has been confirmed that Boryung's new small cell lung cancer drug Zepzelca has received conditional approval only with phase 2 clinical data.

 

Based on the Ministry of Food and Drug Safety's notice, anti-cancer drugs have been subject to conditional approval for phase 3 since January this year, and the revision of the Pharmaceutical Affairs Act has clarified the criteria for conditional approval only with phase 2 data.

 

The HIRA benefit evaluation will be available if the company applies for conditional approval.

 

If the adequacy is evaluated in the HIRA, it can be converted into a reimbursed drug through drug price negotiations with the NHIS.

 

Until the benefit is applied, patients will be able to receive Zepzelca on a nonreimbursed basis only for permits.

 

On July 6, the Central Pharmaceutical Affairs Review Committee, which was unveiled by the Ministry of Food and Drug Safety on the 27th, discussed the efficacy of Zepzelca's conditional approval.

 

According to the minutes, the Ministry of Food and Drug Safety judged that the number of patients was reasonable because the phase 3 clinical trial proposed by Boryung was a multinational clinical trial.

 

In addition, Zepzelca submitted a risk management plan as a rare drug, and added that it focused on hematological toxicity and hepatotoxicity in safety items.

 

At the meeting, Boryung said, "We plan to proceed only with global clinical trials at the moment, and if we believe that domestic clinical trials are necessary, we will decide after discussing with developers." "In the United States, discussions have been held with the FDA several times since the phase 2 clinical trial, and conditional items have been approved and are currently on the market," he explained.

 

Phase 3 clinical trials are currently underway, and plans to submit phase 3 clinical data as soon as clinical trials are completed in the future.

 

Boryung announced its plan to launch Zepzelca in the first half of next year, which is an indication of "metastatic small cell lung cancer that failed primary platinum-based chemotherapy." Zepzelca is a new anti-cancer drug developed by Spanish pharmaceutical company PharmaMar S.A., and Boryung has exclusive rights to develop and sell in Korea since 2017.

 

After being designated as a rare drug by the U.S.

 

Food and Drug Administration (FDA) in 2018, it was released in July of the same year with conditional rapid approval and priority screening approval in June 2020.

 

In the United States, only small cell lung cancer is allowed.

 

Boryung said, "Although it was a phase 2 result, it showed effectiveness compared to existing treatments, and showed a low tendency in hematological adverse reactions in terms of safety," and expected, "If it is marketed, patients' choice opportunities will be expanded."