The US Food and Drug Administration (FDA) has granted priority review to United States-based Merck for its anti-PD-1 therapy Keytruda in certain patients with high-risk, non-muscle invasive bladder cancer (NMIBC), it was reported yesterday.
The new supplemental Biologics License Application (sBLA) for the product, which has been accepted by the US FDA, is for the treatment of patients having Bacillus Calmette-Guerin (BCG) -unresponsive, high-risk, NMIBC. Through the application, the company is looking for approval for the treatment of the condition in patients with carcinoma in-situ (CIS) irrespective of papillary tumours who are not eligible for or have decided not to have their bladder removed.
The sBLA is based on the data from the phase two KEYNOTE-057 trial, which were showcased first at the European Society for Medical Oncology 2018 Congress. The company expects a Prescription Drug User Fee Act or target action date for the anti-PD-1 therapy for the new indication in January 2020.
FDA approval streamlines access to Bristol Myers Squibb CAR T cell therapies
Biovica secures European patent for biomarker use in immuno-oncology
CARsgen Therapeutics' satri-cel NDA accepted by Chinese regulator
Scancell expands Phase 2 SCOPE trial with new intradermal dosing arm for iSCIB1+
Telix Pharmaceuticals delivers first commercial doses from Belgian manufacturing hub
Innovent presents mazdutide Phase 3 clinical study results at ADA 85th Scientific Sessions
Hoth Therapeutics reports positive interim results for HT-001 topical therapy
Aiforia Technologies launches CE-IVD marked AI solution for breast cancer diagnostics
Stockholders approve proposed merger of TuHURA Biosciences and Kineta
Sarclisa recommended for EU approval in newly diagnosed transplant-eligible multiple myeloma
Harbour BioMed and Otsuka collaborate on advancing BCMAxCD3 bispecific T-cell engagers
Dizal completes enrolment in sunvozertinib vs. platinum doublet phase III study
RyboDyn joins Lilly Gateway Labs' innovation hub
GRAIL reports positive results from Galleri multi-cancer early detection test registrational study