Sharon Shacham, PhD, MBA
The FDA has added 3 months to the review period for a new drug application (NDA) for selinexor for the treatment of patients with penta-refractory multiple myeloma, making the new action date July 6, 2019.
In February, however, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 8 to 5 against accelerated approval of the NDA, recommending delaying a decision on the drug until results are available from the pivotal phase III BOSTON trial.
Following the ODAC meeting, the FDA, which is not required to follow the ODAC recommendation, requested further information from Karyopharm as an amendment to the NDA.
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