Boryung Pharmaceutical said that the Ministry of Food and Drug Safety has granted an orphan drug designation (ODD) to Lurbinectedin, a small cell lung cancer (SCLC) treatment.

Boryung’s SCLC treatment won orphan drug designation from the Ministry of Food and Drug Safety on Monday. (Boryung)

Lurbinectedin won the ODD status for treating advanced metastatic SCLC adult patients who have failed primary platinum-based chemotherapy. The disease has an aggressive tendency among lung cancers and a high recurrence rate after treatment, the company said.

In 2017, Boryung obtained exclusive rights to local development and sales from PharmaMar, a Spanish-based multinational pharmaceutical firm.

Boryung plans to apply for local sales licenses this year and aims to release it in 2021 if the approval process goes smoothly.

The U.S. Food and Drug Administration also recognized the drug’s superior safety and effectiveness in June 2019 through comparison with existing treatments after PharmaMar submitted the results of its phase 2 clinical trials. As a result, PharmaMar has obtained phase 3 clinical trial conditional accelerated approval and priority review approval from the FDA in June, the company said.

PharmaMar is conducting global phase 3 clinical trials.

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