Update for September 29, 2020
The FDA accepted a resubmitted BLA for Bluebird Bio’s and Bristol-Myers Squibb’s idecabtagene vicleucel for the treatment of multiple myeloma and set a PDUFA date for 3/27/2021.
The FDA accepted the BLA and the EMA accepted the MAA for UCB’s bimekizumab for the treatment of moderate to severe plaque psoriasis.
ADC Therapeutics submitted a BLA for loncastuximab tesirine for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
The EMA approved Galapagos’ and Gilead’s filgotinib to treat moderate to severe active rheumatoid arthritis.
Announced Research Updates
Sarepta announced 24-month interim results from four patients in a Phase I/II trial, where microdystrophin gene therapy (SRP-9001) improved their North Star Ambulatory Assessment (NSAA) compared to baseline in four ambulatory Duchenne muscular dystrophy participants between the ages of 4 and 7. SRP-9001 increased micro-dystrophin protein levels at 12-weeks, but Sarepta has not reported levels since that time.
Agenus announced that in a 143 patient, Phase II trial, treatment with balstilimab and zalifrelimab resulted in a 22% objective response rate (ORR) in patients with advanced cervical cancer. Agenus announced that in a 160 patient, Phase II trial, treatment with balstilimab resulted in a 14% ORR in patients with advanced cervical cancer.
Published Research Updates
In a 6-week, 45 patient, Phase II trial, reproxalap ophthalmic solution was non-inferior to prednisone acetate ophthalmic solution with or without reproxalap ophthalmic solution in reducing anterior chamber inflammatory cell count in noninfectious uveitis patients.
During the first 12-months of a 24-month extension of the Phase II trial, 23 patients continued to improve velocity to stand from supine, to run/walk 10 meters and to climb 4 stairs after 18 total months of treatment. When the outcomes in 46 vamorolone-treated DMD patients were compared to a group of 68 patients in the CINRG Duchenne Natural History Study (corticosteroid-naive, n = 19; corticosteroid-treated, n = 68) over a similar 18-month period, there was no difference in time to stand, but an improvement in the time to run/walk 10 meters and to climb 4 stairs.
In a 55 patient, Phase II trial, plinabulin was non-inferior to pegfilgrastim in reducing neutropenia in patients receiving docetaxel chemotherapy.
In the 1,032 patient, Phase III, open-label, DANUBE trial, neither durvalumab plus tremelimumab or durvalumab monotherapy improved overall survival compared to standard-of-care chemotherapy in patients with metastatic urothelial carcinoma.
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