SY-5609 is a highly selective and potent oral inhibitor of the cyclin-dependent kinase 7.
Following an initial extensive review, the Agency identified less than 20 cases of SCC and less than 30 cases of various lymphomas in the capsule around the breast implant.
The approval was based on data from the phase 2 FIGHT-203 study, which included 28 patients with relapsed or refractory myeloid/lymphoid neoplasms with FGFR1 rearrangement.
The accelerated approval was based on data from the phase 2 DESTINY-Lung02 trial that included adults with HER2-mutant metastatic NSCLC after 1 prior systemic therapy.
The sNDA is supported by data from the phase 3 PROpel trial which included adults with mCRPC in the first-line setting.
The sBLA is supported by data from the phase 3 DESTINY-Breast04 trials.
DSP-0390 is an inhibitor of emopamil-binding protein, an endoplasmic reticulum membrane protein involved in cholesterol biosynthesis.
Updated findings from the UNITY-CLL trial continue to show a possible increased risk of death among patients who received Ukoniq.
The decision to discontinue was based on data from pre-planned analyses of the phase 3 PIVOT-09 study and the phase 2 PIVOT-10 study.
The test is performed by exhaling into a tube that is connected to the test kit.
