US FDA Lifts Partial Clinical Hold on Karyopharm’s Selinexor Clinical Trials

When there is so much that is negative in the news, it is great to be able to report today that myeloma clinical trials with selinexor (KPT-330) can again move forward.

Darzalex® (daratumumab): more very good news and a caution

Janssen’s Darzalex®, or daratumumab, has been granted “Breakthrough Therapy” designation by the US Food and Drug Administration for use in combination with Revlimid® (lenalidomide) and dexamethasone, and Velcade® (bortezomib) and dexamethasone, for the treatment of multiple myeloma patients who have received at least one previous therapy. The designation was based on data from the CASTOR and POLLUX trials recently presented at ASCO 2016 and EHA 2016 respectively. The prolongation of remissions achieved by combining Darzalex with either Velcade/dex or Revlimid/dex were highlighted in my Myeloma Updates 2016 presentation, as well as recent blogs, “ASCO 2016: More excitement about daratumumab (Darzalex®), and tremendous interest in value and costs” and “Preview of the Black Swan Research Initiative’s First US Cure Trial.”

Daratumumab shows great promise in published report today

The major article today in the New England Journal of Medicine is a report  of a study with lead author, Dr. Henk Lokhorst (from VU University Medical center in Amsterdam, Netherlands) which summarizes the phase I – II trials results in 72 patients treated with daratumumab, anti-CD38 therapy.

FDA Reverses ODAC Vote and Approves Panobinostat (Farydak®) for Relapsed Myeloma

In a surprise move this week, the US Food and Drug Administration (FDA) approved Farydak®, despite the 5-2 vote by the FDA’s Oncologic Drugs Advisory Committee (ODAC) recommending against approval in November 2014. The approval is obviously good news for the myeloma community.

Revlimid Receives Frontline Approval in the US

In a highly anticipated decision announced this week, the US Food and Drug Administration (FDA) approved the use of Revlimid

Pages