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Approval of Boryung¡¯s new SCLC drug Zepzelca imminent

By Lee, Hye-Kyung | translator Alice Kang

22.09.07 12:02:04

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MFDS complete safety and efficacy review... in 2 years since FDA approval



Boryung Pharmaceutical¡¯s new drug for small-cell lung cancer (SCLC), 'Zepzelca inj, (lurbinectedin) is soon to be granted marketing approval in Korea.

Currently, Hycamtin inj (topotecan)¡¯ and ¡®Camtobell Inj (belotecan)¡¯ are approved for second-line use in Korea.

According to industry sources on the 7th, the Ministry of Food and Drug Safety recently completed the safety and efficacy review for Zepzelca recently.

With the safety and efficacy review complete for the drug, it is highly likely that Zepzelca will be approved soon if no variables arise.

Zepzelca is an anticancer drug for which Boryung owns exclusive rights to development and sales in Korea.
Lee, Hye-Kyung(hgrace7@dailypharm.com)
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