Zepzelca by Boryung designated as an orphan Drug

Conditional rapid approval for FDA's Phase III clinical trials in June,

Zepzelca

Boryung announced on the 13th that it is in the process of receiving a new drug called small-cell lung cancer (SCLC) 'Zepzelca' (Lurbinectedin) as an orphan drug.

 

Zepzelca is an anticancer drug that Boryung has exclusive rights to domestic development and sales.

 

In 2017, Boryung signed a technology introduction contract with PharmaMar in Spain.

 

Since Lurbinectedin obtained a sales license from the FDA last month, it is adjusting the timing of its introduction in Korea.

 

It is confirmed that the application of an orphan drug has been recently submitted to the MFDS and the supplementary documents have been submitted.

 

The indication that Zepzelca has been approved for this time is for adult patients with metastatic small cell lung cancer whose disease has progressed since platinum chemotherapy.

 

The FDA made a rapid approval decision based on data from phase II clinical trials that proved superiority in terms of safety and effectiveness through indirect comparison with the existing treatment, Topotecan.

 

The condition is that additional phase III clinical trial data must be submitted to remain approved.

 

Small cell lung cancer is one of the most aggressive types of lung cancer.

 

It has been known to cause metastasis from the early stages and a high recurrence rate after treatment.

 

Anti-cancer drugs currently approved in Korea for secondary treatment for small cell lung cancer include Novartis Korea's 'Hycamtin' (Topotecan) and Chong Kun Dang's 'Camtobell' (Belotecan).

 

Boryung plans to apply for phase III conditional domestic permit application in the same way as the United States when the designation of an orphan drug of Zepzelca is completed.

 

It is expected that the acquisition of a domestic license will be a new treatment option in the field of recurrent small cell lung cancer.

 

Kim Yeong-seok, chief of anticancer drugs at Boryung said, "Small cell lung cancer is a disease with poor prognosis and limited treatment options, but if Lurbinectedin is quickly approved through the designation of an orphan drug, it is expected to provide new treatment options to domestic patients and medical staff."