Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted positive opinions about Amgen, recommending marketing authorization for:
• Kyprolis® (carfilzomib) in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
• BLINCYTO® (blinatumomab) as a conditional marketing authorization for the treatment of adults with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-precursor acute lymphoblastic leukemia.1
What is Multiple Myeloma?
Multiple myeloma is a cancer that begins in plasma cells. In time, myeloma cells collect in the bone marrow and in the solid parts of bones. It affects 20,000 to 200,000 people per year.2
Kyprolis is a proteasome inhibitor for use in the treatment of patients with relapsed multiple myeloma. Proteasomes play an important role in cell function and growth by breaking down proteins that are damaged or no longer needed. Kyprolis blocks proteasomes, which leads to an excessive build-up of proteins within cells. In some cells, Kyprolis can cause cell death, especially in myeloma cells because they are more likely to contain a higher amount of abnormal proteins. Kryprolis was approved in 2012 for the treatment of patients with multiple myeloma who have received at least two prior therapies including bortezomib and an immunomodulatory agent and have demonstrated disease progression on or within 60 days of completion of the last therapy.
What is Acute Lymphoblastic Leukemia?
Acute lymphoblastic leukemia(ALL) is a fast-growing cancer of tge lymphoblasts. It occurs when the bone marrow produces a large number of immature lymphoblasts. The abnormal lymphoblasts grow quickly and replace normal cells in the bone marrow. ALL prevents healthy blood cells from being made. Life-threatening symptoms can occur as normal blood counts drop.3
Blincyto is the first clinical validation of the bispecific T cell engager (BiTE®) platform, an innovative approach that can help the body's own immune system fight cancer. The FDA approved Blincycle last December to treat acute lymphoblastic leukemia.4
The CHMP positive opinions will now be reviewed by the European Commission and if granted, the two products will have marketing authorization in the 28 member countries of the European Union (EU), as well as Iceland, Lichtenstein and Norway.
"We are pleased to receive positive CHMP opinions for Kyprolis and BLINCYTO as this is an important step in providing new treatment options for patients in Europe with rare forms of cancer," said Sean E. Harper, MD, executive vice president of Research and Development at Amgen. "For patients with multiple myeloma, periods of remission become shorter following each new treatment regimen, underscoring the need for additional treatment options. The results of the ASPIRE study demonstrate that Kyprolis extended the time patients live without their disease progressing. Additionally, there is a critical need for new therapies for patients with relapsed or refractory B-cell precursor ALL."
1. Amgen Receives CHMP Positive Opinions For Two New Treatment Options For Patients With Blood Cancer In Europe [news release]. Thousand Oaks, CA; Amgen: September 25, 2015. http://www.prnewswire.com/news-releases/amgen-receives-chmp-positive-opinions-for-two-new-treatment-options-for-patients-with-blood-cancer-in-europe-300149130.html
2. Multiple Myeloma; NIH: National Cancer Institute
. September 25, 2015. https://www.nlm.nih.gov/medlineplus/multiplemyeloma.html#cat78
3. Acute lymphoblastic leukemia (ALL) NIH. February 13, 2015. https://www.nlm.nih.gov/medlineplus/ency/article/000541.htm
4. FDA approves Blincyto to treat a rare form of acute lymphoblastic leukemia [news release]. U.S. Food and Drug Administration: December 3, 2014. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm425549.htm
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