Jun 20, 2019 | Updated: 03:45 PM EDT

AML Or Acute Myeloid Leukemia Patients With IDH2 Mutations Get New FDA Approved Drug, Idhifa, For Treatment

Aug 03, 2017 06:16 AM EDT

On Tuesday, the U.S. Food and Drug Administration approved a new drug that helps treat adults with relapsed or refractory acute myeloid leukemia
(Photo : Wochit News / You Tube) On Tuesday, the U.S. Food and Drug Administration approved a new drug that helps treat adults with relapsed or refractory acute myeloid leukemia. The drug, which is called Idhifa, is reportedly used to find specific mutations in the IDH2 gene in patients with AML. According to the National Institutes of Health, nearly 21, 400 people will be diagnosed with the disease and 10,590 estimated patients will die from it in 2017 alone. Researchers reportedly tested the efficiency of Idhifa in a trial of 199 patients with relapsed or refractory AML before its approval.

The FDA approves a new drug for the treatment of AML or acute myeloid leukemia. The Celgene Corp and the Agios Pharmaceuticals Inc. have developed the new drug, Idhifa.

According to Celgene, the monthly list price of this drug is $24,872. But, the list price doesn't indicate what the patients have to pay actually. The cost that they have to pay from their pocket must be based on the health care insurance plans of an individual and the treatment duration. Patients with AML suffer from the genetic mutation that is very rare.

AML originates from the bone marrow, and it progresses speedily. This cancer causes an abnormal increment of the white blood cells in the body. Generally, this problem is diagnosed in older persons. According to Reuters, this disease is very uncommon for the people under the age limit of 45.

This new drug gets approval from the FDA to treat the refractory or the relapsed AML patients who are the victims of the IDH2 mutation. For the treatment, the patients have to undergo the diagnostic test. Abbott laboratories, developed for mutation detection, perform this test.

For the Celgene Corp the new drug to treat AML, Idhifa, may not be a great needle mover. But it represents first FDA approval for the partnered product, according to Cory Kasimov. Cory Kasimov is the J.P. Morgan analyst.

The FDA approval came after the single-arm trial of the 199 AML patients who had the IDH2 mutations, Pharmacy Times reported. The trials showed the efficacy of the drug. Among these patients who got the treatment for six months, 19 percent experienced complete remission for the duration of an average of eight months. On the other hand, four percent experienced complete remission with the partial hematologic recovery for the duration of an average of 9.6 months.

Notably, FDI has recently approved another important drug, Rydapt, to treat the AML. Popular pharmaceutical company Novartis AG has produced this drug. The important thing is Rydapt has a list price of $7,495 for the 14-day treatment and $14,990 for the 28-day treatment.

However, the FDI approved the Novartis' treatment for those AML patients who are newly diagnosed and carry a particular genetic mutation, FLT3. The approval of Idhifa also brings a warning about the risk of the differentiation syndrome as an adverse reaction. Differentiation syndrome includes respiratory distress, multi-organ dysfunction, fever, and this syndrome could be fatal if left untreated. Idhifa is the only approved therapy by FDA to treat the AML patients with the IDH2 mutation.

Currently, among the AML patients, only eight to nineteen percent suffer from the IDH2 mutation. According to Celgene, around 1200 to 1500 patients belong to this mutation problem in the U.S. An estimate prepared by the American Cancer Society's indicates that in 2017 around 21,380 new cases related to AML will be diagnosed. The estimate has even hinted that about 10,590 patients will succumb to this health disease.

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