Priority Review has been granted by the FDA for a New Drug Application (NDA) seeking accelerated approval for lurbinectedin for the treatment of patients with small cell lung cancer (SCLC) who have progressed after prior platinum-containing therapy.
Spain’s PharmaMar submitted the NDA in December 2019 based on data from the Phase II monotherapy basket trial, which included evaluation of lurbinectedin for the treatment of relapsed SCLC.
The accelerated approval pathway allowed for the submission of an NDA based on the results of Phase II drug investigations for the treatment of serious diseases that address an unmet medical need. The FDA has set a target action date of August 16, 2020.
There remains a critical unmet need for patients with relapsed SCLC, as the treatment landscape has not changed substantially in more than two decades since the last new chemical entity, topotecan, was approved.
Last month, the exclusive license agreement announced between PharmaMar and Jazz Pharmaceuticals became effective, granting the latter US commercialisation rights to lurbinectedin.