Articles tagged with: Thalidomide
Press Releases»
- 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 …
News»

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 …
News, Opinion»

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 …
News»

The American Society of Clinical Oncology will hold its 50th 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 …
News»

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 …
Press Releases»
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 …
News»

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 …