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FDA Grants P-BCMA-101 CAR T-Cell Therapy Orphan Drug Designation for Myeloma

Lisa Astor
Published: Tuesday, May 14, 2019

Eric Ostertag, MD, PhD

Eric Ostertag, MD, PhD

The FDA has granted an orphan drug designation to the autologous CAR T-cell therapy P-BCMA-101 for the treatment of patients with relapsed/refractory multiple myeloma.1

The phase II trial of P-BCMA-101 is expected to begin in the second quarter of 2019 with a potential biologics license application filing by the end of 2020, according to Poseida.

References

  1. Poseida Therapeutics Receives US FDA Orphan Drug Designation for P-BCMA-101 for the Treatment of Multiple Myeloma [press release]. San Diego, CA: Poseida Therapeutics Inc. Published May 13, 2019. https://bit.ly/2YjCMHM. Accessed May 13, 2019.
  2. Gregory T, Cohen AD, Costello CL, et al. Efficacy and safety of P-Bcma-101 CAR-T cells in patients with relapsed/refractory (r/r) multiple myeloma (MM). Blood. 2018;132(suppl 1):1012. doi: 10.1182/blood-2018-99-111419.

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