FDA grants accelerated approval to Tafasitamab-cxix for diffuse large B-cell lymphoma

Summary: The Food and Drug Administration (FDA) has announced the approval of a new medication for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), the most common type of non-Hodgkin lymphoma, who are not eligible for autologous stem cell transplant. The new drug, called Monjuvi (tafasitimab) is a targeted therapy that will be used in combination with lenalidomide (Revlimid). Other combinations are currently under investigation.

Dr. Dan's Takeaway: This is a very exciting time for the treatment of many types of blood cancer. In only the past three years, six new therapies have been approved for relapsed or refractory DLBCL! This influx of new treatments is an amazing success story for targeted and gene-based therapies, but it also means that oncologists have not had time to figure out how best to use these medications in clinical practice. If you have relapsed or refractory DLBCL, make sure to discuss all the options with your oncologist, and don't be afraid to bring new articles or information on treatments to your doctor's attention. Because this field is changing so fast, you may find it easier to keep up with all the new information than your doctor!

Key Points on New Treatments for Relapsed/Refractory DLBCL

  • CAR-T (chimeric antigen-receptor T cells): Yescarta and Kymriah
    • Clinical Use: 3rd-line (two previous regimens have failed)
    • Positives: very effective (40% CR); works quickly
    • Negatives: serious side effects > 20% of patients (CRS; neurologic impairment); cost; takes 2 months to make treatment; only available at major cancer centers
  • Immunotherapy: Keytruda
    • Clinical Use: Very specific subtype called primary mediastinal large B-cell lymphoma (PMBCL)
    • Positives: few serious side effects; available at most hospitals
    • Negatives: not very effective by itself (combinations are being studied)
  • Targeted Therapies (Target)
    • Polivy (CD79b)
      • Clinical Use: 3rd-line in combination with bendamustine and rituximab
      • Positives: very effective (40% CR); few serious side effects (neuropathy)
      • Negatives: increased risk of infections
    • Xpovio (XPO-1)
      • Clinical Use: 3rd-line
      • Positives: patients who respond have a long duration of response; taken by mouth
      • Negatives: modest overall response rate (12% CR); need to figure out the right drugs to use in combination
    • Monjuvi (CD19)
      • Clinical Use: combination with lenalidomide for patients not eligible for stem cell transplant
      • Positives: very effective (43% CR); durable response; few serious adverse events
      • Negatives: currently only indicated in high-risk patients who cannot undergo stem cell transplant

Resources:

https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-tafasitamab-cxix-diffuse-large-b-cell-lymphoma

Deskside with Dr. Dan

“One small way I am personally contributing to education is through sharing my take on academic and industry articles, using my medical background to boil down the jargon and pull out the benefits of the news for you.”

- Dan Platt, M.D.
Chief Medical Officer