Karyopharm Seeks FDA Approval for Selinexor Drug for Multiple Myeloma

July 24, 2018  Source: MedCityNews 89

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The Newton Massachusetts-based company, Karyopharm Therapeutics, who developed a new class of drugs to treat multiple myeloma, is in the process of submitting a new drug application to the FDA for their selinexor drug. This new drug selectively inhibits the nuclear export or SINE, where tumor-suppressing proteins are bound to XPO1 proteins accumulated in cell nuclei. This submission process will be completed by the second half of this year.

Various other approved proteasome inhibitors include Ninlaro (ixazomib), Takeda Pharmaceutical Co.’s Velcade (bortezomib) and Amgen’s Kyprolis (carfilzomib). Celgene’s myeloma-indicated immunomodulators include Pomalyst (pomalidomide), Revlimid (lenalidomide) and Thalomid (thalidomide). Johnson & Johnson’s Darzalex (daratumumab) is the only FDA-approved CD38-targeting antibody.

Penta-refractory includes two immunomodulatory drugs, two proteasome inhibitors and a monoclonal antibody targeting the antigen CD38 with glucocorticoids and an alkylating agent. Karyopharm is also seeking accelerated approval for Penta-refractory disease patients. The submission was based upon Phase IIb STORM study results which the company announced during April. Among 122 Penta-refractory patients, 29 percent responded partially, 25.4 percent responded well with two patients having been completely cured.

Also involved in investigational therapies in the Penta-refractory arena, is Massachusetts-based bluebird bio, whose results of their phase I CAR-T therapy clinical trial revealed an overall response rate of 95.5 percent with a 50 percent complete remission rate. More than 90 percent of Penta-refractory patients have successfully undergone a stem cell transplantation.

By Ddu
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