PharmaMar’s Lurbinectedin Granted as Orphan drug designation by U.S. FDA for Small Cell Lung Cancer(SCLC)
PharmaMar’s Lurbinectedin Granted as Orphan drug designation by U.S. FDA for Small Cell Lung Cancer(SCLC)
Shots:
- Lurbinectedin (PM1183) a compound under clinical investigation an inhibitor of RNA polymerase II, essential for transcription process that is over-activated in tumors with transcription addiction
- The designation may provide certain benefits, with a 7-year market exclusivity if approved leading to an exemption from FDA fees
- SCLC is an aggressive cancer ~18% cancer diagnosed with SCLC, with a number of 34,000 new cases in US alone
