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FDA Schedules ODAC Meeting for Selinexor in Penta-Refractory Myeloma

Gina Columbus @ginacolumbusonc
Published: Thursday, Feb 07, 2019

The FDA has scheduled an Oncologic Drugs Advisory Committee (ODAC) hearing for February 26, 2019, to discuss a new drug application (NDA) for selinexor in combination with dexamethasone for the treatment of patients with penta-refractory multiple myeloma.1

Selinexor is being investigated in several ongoing phase III trials, including in combination with bortezomib and dexamethasone (BOSTON; NCT03110562), in combination with various backbone treatments (STOMP; NCT02343042), in dedifferentiated liposarcoma (SEAL; NCT02606461), and an investigator-sponsored study in endometrial cancer (SIENDO; NCT03555422).

References

  1. Karyopharm Announces FDA Advisory Committee Meeting to Review Selinexor for the Treatment of Patients with Triple Class Refractory Multiple Myeloma Who Have Received At Least Three Prior Therapies. Karyopharm Therapeutics, Inc. Published February 7, 2019. https://yhoo.it/2TE9XE6. Accessed February 7, 2019.
  2. Chari A, Vogl DT, Dimopoulos MA, et al. Results of the pivotal STORM study (Part 2) in penta-refractory multiple myeloma (MM): deep and durable responses with oral selinexor plus low dose dexamethasone in patients with penta-refractory MM. In: Proceedings from the 2018 ASH Annual Meeting; Dec. 1-4, 2018; San Diego, CA. Abstract 598.

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