The FDA’s Oncologic Drug Advisory Committee will be held on March 15, 2024, to review data pertaining to the supplemental biologics license application of ide-cel in relapsed or refractory multiple myeloma.
The FDA’s Oncologic Drug Advisory Committee (ODAC) will convene on March 15, 2024, to review data from the phase 3 KarMMa-3 study (NCT03651128) of ide-cel in patients with triple class-exposed relapsed/refractory (R/R) multiple myeloma.1 It is anticipated that the data will be related to the key secondary end point of OS that were presented at the 2023 American Society of Hematology (ASH) Annual Meeting.
The supplemental biologics license application (sBLA) of ide-cel had a Prescription Drug User Fee Act target action date of December 16, 2023. On November 20, 2023, the FDA announced that it would review the application at an ODAC meeting and a decision on the sBLA would not be made by the target action date.2
Further, on November 28, 2023, the FDA announced it would investigate reports of secondary malignancies following treatment with CAR T-cell therapies, including ide-cel.3
At ASH, investigators of the KarMMA-3 study presented final progression-free survival (PFS) and interim OS findings. With a median follow-up of 30.9 months, range, 12.7–47.8), investigators observed a 51% reduction in risk of disease progression or death (HR, 0.49; 95% CI, 0.38-0.63). KarMMA-3 also represented the longest follow-up time of a randomized phase 3 study of a CAR T-cell therapy in this intent-to-treat population.4 The median PFS for patients treated with ide-cel was 13.8 months (range, 11.8-16.1) vs 4.4 months (range, 3.4-5.8) with standard regimens.5 The median OS was 41.4 months in the ide-cel arm vs 37.9 months in the control arm.6
Landgren on MRD as an End Point for Multiple Myeloma Trials
May 1st 2024C. Ola Landgren, MD, PhD, discussed the FDA’s unanimous ODAC vote supporting minimal residual disease as an accelerated approval end point in multiple myeloma and the implications of this vote in the myeloma research field.
Read More
Age, Disease Burden Are Factors in Early Use of Selinexor in Multiple Myeloma
April 22nd 2024During a Case-Based Roundtable® event, Jonathan L. Kaufman, MD, discussed treatment approaches and the tolerability of a selinexor-containing regimen in a patient with relapsed/refractory multiple myeloma in the first article of a 2-part series.
Read More