Amgen, Inc. (NASDAQ:AMGN) has received the approval for its innovative drug BLINCYTO from the US FDA. The FDA has given approval for the new drug to treat children and adults suffering from B-cell precursor acute lymphoblastic leukemia with minimum residual disease (MRD) of 0.1% or greater. This approval is based on the outcome of hematological relapse-free survival and the rate of MRD response.
It is the first drug to get the approval from FDA for the treatment of MRD. The continued approval of the drug will depend on the outcome of the clinical trials.
MRD represents the detectable cancer cells present in the patient body and can be measured with the help of highly sensitive methods. The apparatus used for detecting the cancer cells in the bone marrow should have a sensitivity of identifying at least one cancer cell in a group of 10,000 cells.
The Senior Vice President (Translational Sciences and Oncology) at Amzen, Mr. David M. Reese, M.D. said till date no medicine is available to completely treat MRD. The FDA approval for BLINCYTO to cure MRD is a great achievement and can be used for the treatment of high risk patients.
Many patients are treated for leukemia completely. But, detecting the remaining cancer cells is vital for preventing relapse of the disease and obtain a better result. The associate professor (Leukemia Department) at the University of Texas, Mr. Elias Jabbour said it is vital to conduct the tests on patients to know the status of MRD and provide treatment for better results.
According to the BLAST study, around 80% of the patients administered with BLINCYTO are free from detectable cancer cells. Therefore, FDA approval for this drug is a significant step to destroy the balance Leukemia cancer cells in patients.
The results obtained from Phase 2 clinical trials is an indication that BLINCYTO is able to turn the patients with MRD positive to MRD negative state with a single therapy.
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