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  • Prostate cancer drug Pluvicto¡¯s approval imminent in Korea
  • by Eo, Yun-Ho | translator Kim, Jung-Ju | Apr 24, 2024 05:44am
Novartis¡¯ radioligand therapy for metastatic castration-resistant prostate cancer
MFDS conducts final review...approval expected in first half of the year
Demonstrated a reduction in the risk of death through Phase III VISION trial
The new metastatic castration-resistant prostate cancer drug ¡®Pluvicto¡¯ is set to soon be commercialized in Korea.

According to industry sources, the Ministry of Food and Drug Safety is in the final stages of reviewing Novartis Korea's targeted radioligand therapy ¡®Pluvicto (lutetium (177Lu) vipivotide tetraxetan)¡¯ for its marketing authorization. Its formal approval is expected in the first half of the year.

In June 2023, Pluvicto was recognized by the MFDS for its innovation and designated the drug as the 6th drug in the Global Innovative products on Fast Track (GIFT) program.

In addition, Novartis has also applied to participate in the pilot approval-evaluation-negotiation linkage system wit
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