• U.S. FDA grants Priority Review for dara­tu­mu­mab in com­bi­na­tion with bor­tez­o­mib, thalido­mide and dexa­meth­a­sone as treat­ment for newly diag­nosed patients with multiple myeloma who are can­di­dates for au­tol­o­gous stem cell trans­plant
• September 26, 2019 PDUFA date

Copenhagen, Denmark (Company Announcement) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the U.S. Food and Drug Admin­istra­tion (U.S. FDA) granted a Priority Review for the supple­mental Biologics License Application (sBLA) for the use of dara­tu­mu­mab (DARZALEX®) in com­bi­na­tion with bor­tez­o­mib, thalido­mide and dexa­meth­a­sone (VTd) as treat­ment for patients newly diag­nosed with multiple myeloma who are can­di­dates for au­tol­o­gous stem cell trans­plant (ASCT). The sBLA was submitted by Genmab’s licensing partner, Janssen Biotech, Inc. (Janssen), in March 2019. Priority Review is a …

Good morning, myeloma world.

As we were finalizing today's edition of Myeloma Morning, we were suddenly reminded of how inter­na­tional the field of multiple myeloma research truly is.

The first research study we review below is by a team of German researchers. We also discuss two studies by Korean researchers, and a topic sparked by a report written by Chinese researchers. At the end of today's report, the list of new myeloma research articles also in­cludes publications by investigators in India, Israel, Italy, and the United States.

As we …

It’s July, and we have had some time to digest the findings from the American Society of Clinical Oncology (ASCO) annual meeting held in Chicago May 30 through June 3.

Quite a few pre­sen­ta­tions caught one’s eye.

We finally saw the results of the much awaited PANORAMA-1 study in­ves­ti­gating the efficacy and safety of panobinostat (LBH589) plus Velcade and dexa­meth­a­sone com­pared to Velcade and dexa­meth­a­sone alone.

Exciting data on the CD38 anti­bodies daratumumab and SAR650984 continued to emerge at ASCO.

Another study looked at a pro­gres­sion-free …

The American Society of Clinical Oncology will hold its 50^th annual meet­ing May 30 through June 3 in Chicago.

Similar to pre­vi­ous years, more than 25,000 physicians and re­searchers from all over the world are ex­pec­ted to attend the five-day meeting to dis­cuss the current re­search in cancer treat­ment and care.

During the meeting, there will be pre­sen­ta­tions about all areas of cancer, in­clud­ing many focused specifically on multiple myeloma. The ASCO website cur­rently lists in­for­ma­tion about more than 60 myeloma-related studies (included under either the "multiple myeloma" or "plasma cell …

One of the key presentations during the recent American Society of Hematology (ASH) annual meeting in New Orleans was one that summarized initial results of a large international Phase 3 clinical trial known as the "FIRST", or MM-020, trial.

The trial results show that continuous administration of Revlimid and dex­a­meth­a­sone improves response rates as well as progression-free and overall survival in newly diagnosed multiple myeloma patients who are older or not eligible for stem cell transplantation.

Specifically, the researchers found that the overall response rate was highest (75 percent) among patients who received …

Company Completes Key Step in Process to Submit Product Application

Philadelphia (Press Release) - Lannett Company, Inc. (NYSE MKT: LCI) today announced that it has suc­cess­fully com­pleted a key step in its effort to submit to the U.S. Food and Drug Admin­istra­tion (FDA) an Abbre­vi­ated New Drug Application (ANDA) for Tha­lid­o­mide Capsules. The com­pany believes that it con­tin­ues to be on track to submit its ANDA for Tha­lid­o­mide Capsules by January 2014.

As part of its prod­uct devel­op­ment activities for Tha­lid­o­mide Capsules, Lannett commenced bio-equivalency studies in fasting and fed con­di­tions in …

Results from a recent French study based on data from clinical practice indicate that vitamin K antagonists and low-molecular weight heparin are more effective than aspirin in preventing clots during myeloma treatment with the immuno­modu­la­tory drugs thalidomide or Revlimid.

Specifically, 7 percent of patients receiving aspirin developed blood clots, compared to 3 percent of patients receiving low-molecular weight heparin and 0 percent receiving a vitamin K antagonist such as warfarin (Coumadin).

Interestingly, the rate of blood clot formation was lowest among patients with the highest risk of developing blood clots, which the …