The Myeloma Beacon Staff's Archive

The Myeloma Beacon Staff has written 730 article(s) .

[ by | Mar 3, 2015 10:36 pm | 7 Comments ]
High-Dose Kyprolis Extends Progression-Free Survival Versus Velcade In Head-To-Head Relapsed Myeloma Trial

Initial results of a large, head-to-head clinical trial show that relapsed myeloma patients treated with high-dose Kyprolis and dex­a­meth­a­sone had twice the progression-free survival of relapsed patients treated with Velcade and dex­a­meth­a­sone.

Median progression-free survival in the Phase 3 trial was 18.7 months in trial participants treated with high-dose Kyprolis (carfilzomib) and dex­a­meth­a­sone (Decadron), compared to 9.4 months in patients treated with Velcade (bor­tez­o­mib) and dex­a­meth­a­sone.

The results of the so-called “ENDEAVOR” trial were announced …

Tags: , , , ,
Read the full story »
[ by | Feb 26, 2015 7:40 pm | 3 Comments ]
Farydak – Questions & Answers About The FDA Approval

The U.S. Food and Drug Administration (FDA) on Monday approved Farydak (panobinostat) for the treatment of multiple myeloma (see related Beacon news).

Since the FDA announced its decision, multiple myeloma patients, care­givers, and health care professionals have been asking a number of important questions about Farydak. This article compiles many of those questions and provides answers to them.

The information in this article is based primarily on the official, FDA-approved prescribing information for Farydak. …

Tags: , , , ,
Read the full story »
[ by | Feb 23, 2015 3:30 pm | 13 Comments ]
FDA Approves Farydak (Panobinostat) For The Treatment Of Relapsed Multiple Myeloma

The U.S. Food and Drug Administration (FDA) has approved panobinostat, which will be marketed under the brand name Farydak, for the treatment of relapsed and refractory multiple myeloma.

Specifically, Farydak has been approved for use in combination with Velcade (bortezomib) and dexamethasone (Decadron) in patients with multiple myeloma who have received at least two prior standard therapies.

The two prior therapies must include Velcade and at least one treatment from the immunomodulatory class of drugs, …

Tags: , , , ,
Read the full story »
[ by | Feb 18, 2015 7:43 pm | 2 Comments ]
FDA Broadens Revlimid's Approved Use To Include Newly Diagnosed Multiple Myeloma

The U.S. Food and Drug Administration (FDA) has ex­panded the of­ficial­ly ap­proved use of Revlimid to include the treat­ment of newly diag­nosed multiple myeloma.

Previously, Revlimid’s approval in the U.S. and elsewhere in the world was for the treat­ment of myeloma patients who have re­ceived at least one prior therapy.

With the expanded U.S. approval, there no longer is any re­striction regard­ing prior therapies in the FDA-approved pre­scrib­ing in­for­ma­tion for Rev­limid (lena­lido­mide).

The new edition of the pre­scrib­ing …

Tags: , , ,
Read the full story »
[ by | Feb 11, 2015 8:25 am | 13 Comments ]
Ixazomib Succeeds In Key Phase 3 Relapsed Multiple Myeloma Trial – Approval Filings Expected Later This Year

Takeda Oncology yesterday announced posi­tive results from a key trial testing the in­ves­ti­ga­tional drug ixazomib in relapsed multiple myeloma patients.

Participants in the large Phase 3 ixazomib trial, known as the TOUR­MA­LINE MM-1 study, received one of two possible treatment regimens. One group was treated with ixazomib, Revlimid (lenalidomide), and dexa­metha­sone (Decadron), while the other group received a placebo (sugar pill), Revlimid, and dexa­metha­sone.

Investigators conducting the trial recently carried out the first planned …

Tags: , ,
Read the full story »