Promising Developments in Treatment of Multiple Myeloma!
As you may know multiple myeloma can present itself in different ways and with different symptoms and the exact cause is still not known. Mayo Clinic state “Doctors know that myeloma begins with one abnormal plasma cell in your bone marrow — the soft, blood-producing tissue that fills in the centre of most of your bones. The abnormal cell multiplies rapidly.” For some the disease can remain inactive, for some the prognosis is not so favourable. However, the good news is that this form of cancer does respond well to multiple treatments. Among new therapies being trialled there is one that could provide a new option to patients.
To quote from recent news coverage:
“Data from the Janssen Research & Development Phase 3 ALCYONE study, showed that Darzalex (daratumumab) in combination with bortezomib, melphalan, and prednisone (VMP) significantly improved clinical outcomes, including reducing the risk of disease progression or death by 50 percent, in patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation (ASCT).”
These results were presented at the American Society of Hematology Annual Meeting in Atlanta and published simultaneously in the New England Journal of Medicine – a highly reputable medical journal.
So, what does this mean?
- This is describing a combination therapy – that is when a special formulation of several drugs often has greater results than one medicine individually.
- The reference to ASCT means stem cell transplantation, which has been the standard treatment for myeloma in ‘young’ patients with adequate organ function but the risk of relapse is high and problematic especially in some patients.
- The efficacy shown in the published study is very promising – almost a 50 % reduction in progression of the disease and chance of death in newly diagnosed patients.
- The three other substances than Darzalex are called together VMP – Velcade- Melphalan-Prednisone
It’s important to note, that differently from prior clinical studies used to support approval of daratumumab (Darzalex), this study was conducted with newly diagnosed myeloma patients.
What is bortezomib and the other substances mentioned?
These are luckily quite available medicines that have already been approved for use with myeloma by many health authorities. This is great news for patients because the combination should be accessible. For example, bortezomib is approved in the U.S. for treating relapsed multiple myeloma and mantle cell lymphoma. In multiple myeloma, it has shown to generate complete responses in patients with otherwise rapidly advancing disease symptoms. Bortezomib is a type of drug called a proteasome inhibitor. Proteasomes are in cells. They help to break down proteins that the cell doesn't need. Bortezomib blocks the proteasomes so the proteins build up inside the cell resulting in the death of the cell.
What does this news mean to you or a loved one?
Well, the great news is, that on November 21, 2017, Janssen submitted an application to the U.S. Food and Drug Administration (FDA) and to the European Medicines Agency (EMA) for this combination therapy and requested Priority Review, which would shorten the review period to just six months (compared to 10 months normally). If approved, this would allow Darzalex (daratumumab) and VMP therapy described to be used as a frontline therapy – which means, doctors would be allowed to treat patients with this option first. This is great news and we will update this blog when the approval is granted!
If you have any enquiries regarding Darzalex (daratumumab), please visit our product page for fuller details, or Contact Us for more details.
References and Further Reading
- Multiple myeloma
Mayo clinic, december 2017
- Cancer Stat Facts: Myelom
National Cancer Institute, SEER Cancer Statistics Review (CSR) 1975-2014
- Janssen's Darzalex Combo Regimen Improved Multiple Myeloma Outcomes
Pharmaceutical Processing, December 2017
- Treatment Of Autologous Stem Cell Transplant-Eligible Multiple Myeloma Patients: Ten Questions And Answers
Heamatologica, March 2014
- Bortezomib (Velcade)
UK Cancer Research, July 2017
- Genmab Announces Submission of Supplemental Biologics License Application to FDA for Daratumumab in Front Line Multiple Myeloma
- Janssen Seeks Expanded Use of DARZALEX (daratumumab) from EMA in Newly Diagnosed Multiple Myeloma
Janssen, November 2017
- Daratumumab plus Bortezomib, Melphalan, and Prednisone for Untreated Myeloma
The New England Journal of Medicine, February 2018