Update for June 1, 2022
The FDA approved tapinarof 1% cream (Vtama, Dermavant Sciences), on 5/24/2022, for the treatment of plaque psoriasis.
The FDA accepted the BLA for etranacogene dezaparvoveca, a one-time treatment for hemophilia B, with a potential PDUFA date of 11/24/2022.
The FDA accepted the BLA for mirvetuximab soravtansine to treat folate receptor alpha-high, platinum-resistant ovarian cancer and set a PDUFA date for 11/28/2022.
The FDA accepted the NDA for omaveloxolone for the treatment of Friedreich’s ataxia and set a PDUFA date for 11/30/2022.
The FDA requested additional, unspecified information for valoctocogene roxaparvovec, so BioMarin is delaying submission of an NDA until the end of September 2022.
The FDA extended the PDUFA date for ublituximab, to 12/28/2022, to allow time to review new data requested by the FDA.
Announced Research Updates
Concert announced that in a 24-week,706 patients, Phase III, THRIVE-AA1 trial, treatment with CTP-543 resulted in achievement of a SALT score of 20 or less in 41.5% of patients treated with 12 mg and 29.6% who received 8 mg compared to 0.8% with placebo in patients with moderate to severe alopecia areata.
Lilly announced that in the 40-week, 544 patient, Phase III, LUCENT-2 trial, patients who achieved remission in the LUCENT-1 induction trial were re-randomized to mirikizumab or placebo. 49.9% of patients treated with mirikizumab achieved or maintained remission compared to 25.1% with placebo
Pfizer announced that in the 52-week, 433 patient, Phase III, ELEVATE UC 52 trial, 32.1% of patients treated with etrasimod achieved remission compared to 6.7% with placebo in patients with moderately-to-severely active ulcerative colitis.
Elevar announced that in an 80 patient, Phase II trial, treatment with apatinib resulted in an ORR of 15.1% in patients with progressive recurrent or metastatic adenoid cystic carcinoma.
SpringWorks announced that in a 142 patient, Phase II trial, treatment with nirogacestat reduced PFS by 41% compared to placebo in patients with desmoid tumors.
Published Research Updates
In the 12-week, 1,162 patient, Phase III, LUCENT-1 trial, 24.2% of patients treated with mirikizumab achieved remission compared to 13.3% with placebo in patients with moderate-to-severe active ulcerative colitis.
The Phase III, BRIGHTER trial was discontinued after 714 patients when an interim analysis found no improvement in the overall survival from adding napabucasin to nab-paclitaxel and gemcitabine compared to the two drugs alone in the treatment of metastatic pancreatic ductal adenocarcinoma.
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