Tags : SCLC

G1 Therapeutics Reports the US FDA Acceptance and Priority Review

Shots: The NDA submission is based on three clinical studies in which Trilaciclib was administered prior to chemotherapy treatment in patients with SCLC and has demonstrated robust myelopreservation benefits. The company anticipates the PDUFA date as Feb 15, 2021 G1 is making Trilaciclib available to SCLC patients in the US, who are unable to enter […]Read More

PharmaMar’s Lurbinectedin Granted as Orphan drug designation by U.S. FDA

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 […]Read More