FDA has granted Priority Review to capmatinib's (INC280) New Drug Application.
FDA has granted Breakthrough Therapy designation for Padcevtm in combination with Merck's anti-PD-1 therapy Keytruda (pembrolizumab) in patients with unresectable locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy in the first-line setting.
FDA has accepted the Biologics License Application of valoctocogene roxaparvovec for Priority Review.
FDA has granted approval Pemfexy, a pemetrexed injection ready-to-dilute formulation for locally advanced or metastatic nonsquamous non-small cell lung cancer in combination with cisplatin and other indications.
Bristol-Myers Squibb Co. said FDA has accepted for Priority Review its Biologics License Application for lisocabtagene maraleucel (liso-cel), the company's autologous anti-CD19 CAR T-cell immunotherapy with a defined composition of purified CD8+ and CD4+ CAR T cells for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after at least two prior therapies. The FDA has set a Prescription Drug User Fee Act goal date of Aug. 17.
FDA has accepted Seattle Genetics' new drug application for its investigational medicine tucatinib for Priority Review.
FDA has granted Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced head and neck squamous cell cancer who are not eligible for platinum-based chemotherapy.
Myriad Genetics has submitted a supplementary premarket approval application to FDA for its myChoice CDx test to help identify women with advanced ovarian cancer who are potential candidates for maintenance therapy with Lynparza (olaparib) in combination with bevacizumab.
European Medicines Agency accepted the Marketing Authorization Application for tucatinib, in combination with trastuzumab and capecitabine, for the treatment of adult patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received at least two prior anti-HER2 treatment regimens.
European Medicines Agency validated the marketing authorization application for belantamab mafodotin for the treatment of patients with relapsed or refractory multiple myeloma whose prior therapy included an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.
