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.
It's important to note that not all patients with multiple myeloma or healthcare professionals treating it have access to the same medicines at the same time, as medicines may be approved and available in one country and not in another. This is because there is no global, harmonised approval system.
There’s a lack of awareness that patients can import medicines on a ‘named patient’ basis, under certain conditions. If you or someone you know wants to find out more about accessing a medicine not currently available in their country, find helpful information on our home page about how we can help. Our team delivers not yet approved medicines from around the world on daily basis, with service that’s highly rated by doctors and patients.
So, what do the results 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
Note, 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.
We also wrote one of the first articles covering Darzalex (daratumumab), back in 2016 when it was first approved as a monotherapy for multiple myeloma, which you might find interesting too.
References and Further Reading