Further FDA clinical trial holds may signal the end for checkpoint inhibitors in myeloma

With the placement of two more checkpoint inhibitor combination trials on partial hold, the US Food and Drug Administration (FDA) has now halted all such trials from four different pharmaceutical companies: Merck, Bristol-Myers Squibb, Celgene, and now Roche.  Roche and its subsidiary Genentech announced that the agency has placed a partial hold on two trials that combine atezolizumab (Tecentriq®) with lenalidomide (Revlimid®) or pomalidomide (Pomalyst®) to treat relapsed/refractory multiple myeloma.

University of California girds to combat cancer, a closer look at CAR-T cell therapy, and medical tourism to China—a wave of the future?

With new drug approvals and expanded indications for new myeloma drugs at an all-time high, there is a sense of optimism in the myeloma community. Yet, even as patients experience longer survival, myeloma remains very sneaky. The disease can evolve into resistant relapse phases, demanding new therapy.

Closing or Halting of Myeloma Immune Therapy Trials: A Major Setback for Patients and Drug Companies

When the US Food and Drug Administration (FDA) halted three Keytruda (pembrolizumab) clinical trials recently because of unexpected deaths, it was cause for concern. This week, the FDA has acted to close further studies involving the whole range of PD-1/ PD-L1 inhibitors combined with the IMiDs Revlimid (lenalidomide) and Pomalyst (pomalidomide) in order to forestall any further unexpected toxicities and/or deaths.

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.”

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