My Thank You Email To The FDA, Which Applies To The Entire #Myeloma Care Team!

FDA, Thank You Again For giving #Myeloma Patients A new LAST CHANCE AT LIFE!

Thank you for the approval of belantamab mafodotin for late stage myeloma treatment.  The myeloma patient community believes the cooperative efforts instituted in the FDA orphan drug program has given myeloma patients so many added years of life.  When I was diagnosed 13 years ago life expectancy was just 33 month.  It is now TWICE as long!  The following is the reason we have belief we have a future.


Myeloma patients should feel blessed to know they have had 10 new drugs and drug classes approved in the last 16 years all of which all had two FDA designations.   In addition, Myeloma (an orphan disease) has  7 drugs which  all had two FDA designations, but have yet to be approved.  These drugs include the following:

Drug                             Company                 Designations      Description

CLR131                         Cellectar                      OD&FT           Radiotherapeutic phospholipid 

JNJ-4528                       Janssen                       OD&BT          CAR-T with two BCMS-targeting
                                                                                                     Single domain antibodies 
CT053                            CARsgen                  OD, RMAT*       A fully human anti-BCMA CAR--T                                                                                                      

bb2121                          Celgene                       OD&BT          BCMA chimeric antigen receptor
                                                                                                    CAR T
Galinpepimut-S              Sellas                        OD&FT           Immunotherapy vaccine to elicit 
                                                                                                    strong response against WT1
P-BCMA-101                   Poseida                  OD,FT&BT         Autologous chimeric antigen
                                                                                                      receptor(CAR) T-cell therapy
Melflufen                  Oncopeptides                 OD&AA            Activated by aminopeptidases, 
                                                                                                      overexpressed in myeloma
So how have we fared with this list?

AMG420 - has dropped from the list in favor of a kinder gentler similar drug called AMG701, however AMG701 has only one FDA designation.

All of the other drugs on the list are progressing very well, with  bb2121 expected to be approved in the next several months.  

Best Regards/ Gary Petersen editor@myelomasurvival.com