June 21 Quick Takes: Priority review for bluebird’s lovo-cel

FDA set a Dec. 20 PDUFA date for gene therapy lovotibeglogene autotemcel (lovo-cel) from bluebird bio Inc. (NASDAQ:BLUE), which the agency granted priority review to treat sickle cell disease. The ex vivo therapy delivers the β-globin gene; it would be bluebird’s third approved product after Zynteglo betibeglogene autotemcel to treat thalassemia and Skysona elivaldogene autotemcel for cerebral adrenoleukodystrophy. Ahead of lovo-cel in sickle cell disease, CRISPR Therapeutics Inc. (NASDAQ:CRSP) and Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) have Dec. 8 PDUFA date for ex vivo gene editing therapy exagamglogene autotemcel. 

Talzenna talazoparib from Pfizer Inc. (NYSE:PFE) gained FDA approval in combination with Xtandi enzalutamide to treat metastatic castration-resistant prostate cancer patients with homologous recombination repair mutations. Pfizer’s drug was already approved for breast cancer. The approval follows by less than a month FDA’s approval of Lynparza olaparib from AstraZeneca plc (LSE:AZN; NASDAQ:AZN) plus abiraterone to treat BRCA-mutant mCRPC, another sign of PARP inhibitors’ growing importance in the evolving landscape for the disease...