IDHIFA

IDHIFA is a unique form of treatment that differs from traditional chemotherapy. It belongs to a class of medications known as IDH2 inhibitors and is specifically designed for individuals with relapsed or refractory AML who have an IDH2 mutation. The details provided below will assist you in comprehending your IDHIFA treatment.

The price of a 30-day supply of Idhifa oral tablets 50 mg can vary, but it is typically around $33,780, depending on the pharmacy you choose.

On August 1, 2017, Celgene Corp.’s enasidenib (IDHIFA) received regular approval from the FDA for the treatment of relapsed or refractory AML.

This treatment is known as intrathecal chemotherapy, which is used to prevent the spread of leukemia cells to the central nervous system (CNS) as part of CNS-directed prophylaxis. Intrathecal chemotherapy is administered throughout all phases of your treatment.

Date: August 1, 2017
Article: FDA Approves Idhifa (enasidenib) for Relapsed or Refractory Acute Myeloid Leukemia with IDH2 Mutation

Temozolomide and capecitabine are both classified as chemotherapy drugs. Temozolomide specifically belongs to the alkylating agents class of medications.

Taxol, also known by its generic name paclitaxel, is a drug that stabilizes microtubules. It has been approved by the Food and Drug Administration for the treatment of ovarian, breast, and lung cancer, as well as Kaposi’s sarcoma.

Chemotherapy is a treatment option for kidney cancer that involves the use of cytotoxic drugs. These drugs work by interfering with the growth and division of cancer cells, ultimately leading to their destruction.

Diffuse large B-cell lymphoma (DLBCL) has a rapid growth rate and is typically treated with chemotherapy, specifically a combination of four drugs called CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone), along with the monoclonal antibody rituximab (Rituxan).

The use of chemotherapy and radiotherapy as treatment methods carries the potential risk of developing therapy-related myeloid leukemia (TRML). TRML cases have been reported in association with the administration of Oxaliplatin, Capecitabine, and radiation therapy. These treatments can cause DNA damage, which may result in the development of a secondary disease.

Out of the 199 patients who were treated with IDHIFA, 19 percent achieved complete remission, with no evidence of disease and full recovery of blood counts, lasting for approximately 8 months.

In clinical trials involving patients with AML, it was found that 50% of patients experienced their initial response to Idhifa within an average of 1.9 months, with a range of 0.5 to 7.5 months. Additionally, half of the patients achieved their best response to Idhifa after an average of 3.7 months, with a range of 0.6 to 11.2 months.

The median duration of complete remission (CR) for patients treated with VENCLEXTA + azacitidine was 18 months, whereas for patients treated with azacitidine alone, it was 13 months.

The recommended treatment for previously untreated CLL or SLL is a 12-month combination of Venclexta and Gazyva.

Hair loss is not expected to occur with Venclexta, as it was not observed as a side effect in clinical trials. However, it is important to note that other cancer medications, such as chemotherapy, may cause hair loss.

Serious adverse effects may occur, including kidney failure, the requirement for dialysis treatment, and potential fatality. It is crucial to attend scheduled appointments for TLS tests conducted by your healthcare provider. Additional medications will be administered before and during VENCLEXTA treatment to minimize the risk of TLS.

Venetoclax is unique in that it allows for specific treatment durations of 12 months for initial therapy and 24 months for recurring or resistant cases. This has a positive effect on patient adherence to the treatment plan and also has favorable implications for the cost of medication.

Patients with intermediate-risk AML have cure rates of around 50 percent to 60 percent when undergoing allogeneic transplantation using stem cells or bone marrow from a tissue-matched sibling or unrelated donor.

The U.S. Food and Drug Administration has granted approval for Idhifa (enasidenib), a new targeted treatment for adult patients with relapsed or refractory acute myeloid leukemia (AML) who possess a specific genetic mutation.

Yes, all Medicare prescription drug plans provide coverage for Idhifa.

Rye Brook, N.Y., December 8, 2023 Jaypirca® (pirtobrutinib) has been granted approval by the U.S. Food and Drug Administration for the treatment of adults suffering from chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has deteriorated or relapsed after undergoing at least two prior treatments.

On September 15, 2021, Takeda Pharmaceuticals, Inc.’s mobocertinib (Exkivity) received accelerated approval from the FDA for the treatment of metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations.

Bosutinib (Bosulif, Pfizer) was granted approval by the Food and Drug Administration on September 26, 2023, for the treatment of chronic phase (CP) Ph+ chronic myelogenous leukemia (CML) in pediatric patients aged 1 year and above. This approval applies to patients who are newly diagnosed (ND) or have shown resistance or intolerance (R/I) to previous therapies.

In addition to standard chemotherapy, the FDA-approved small-molecule drugs for AML include IDH inhibitors (olutasidenib, ivosidenib, enasidenib), FLT3 inhibitors (gilteritinib, midostaurin), BCL-2 inhibitor (venetoclax), hypomethylating agents (azacitidine, decitabine), and CPX-351 (liposomal cytarabine).

Somatic mutations in the IDH1 and IDH2 genes are found in approximately 6% to 16% and 8% to 19% of adult patients with AML, respectively. However, these mutations are rare in pediatric AML, occurring in less than 4% of patients.

Date: August 1, 2017
Article: FDA Approves Idhifa (enasidenib) for Relapsed or Refractory Acute Myeloid Leukemia with IDH2 Mutation

Idhifa is a medication that contains a compound that inhibits the activity of isocitrate dehydrogenase 2 (IDH2). This drug specifically targets mutant IDH2 variants and helps reduce levels of 2-hydroxyglutarate, while also promoting the development of mature myeloid cells.

The suggested initial dose of IDHIFA is 100 mg to be taken by mouth once a day, with or without food, until either the disease progresses or unacceptable side effects occur. For patients who do not experience disease progression or unacceptable side effects, the treatment should continue for at least 6 months to allow for a potential clinical response.

IDHIFA® (enasidenib) is approved by the FDA for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia and have a specific genetic mutation called isocitrate dehydrogenase-2. This mutation can be detected using an FDA-approved test.

On August 1, 2017, Celgene Corp.’s enasidenib (IDHIFA) received regular approval from the FDA for the treatment of relapsed or refractory AML.

The monthly cost for Idhifa is approximately $28,246, with a starting dose of 100 mg per day for patients. Celgene, the manufacturer, offers a copay program and a patient assistance program to assist eligible patients in affording Idhifa.

Enasidenib has a terminal half-life (mean) of 137 hours with a coefficient of variation of 41%.

Agios and Celgene Corporation, which is now a subsidiary of Bristol Myers Squibb, formed a partnership in 2010 to concentrate on cancer metabolism. As per the agreement, Celgene has exclusive rights for the global development and commercialization of IDHIFA® (enasidenib).

IDH inhibitors change the function of IDH enzymes, leading to a decrease in the conversion of ?±-ketoglutarate (KG) to D-2-hydroxyglutarate (2-HG), which acts as a competitor to ?±-KG.

The isocitrate dehydrogenase 2 enzyme, encoded by the IDH2 gene, is located in the mitochondria and plays a crucial role in generating energy for cellular functions.

IDH1 and IDH2 are important metabolic enzymes responsible for converting isocitrate to ?±-ketoglutarate. Mutations in these enzymes are associated with specific types of cancer, such as low-grade gliomas, secondary glioblastomas, chondrosarcomas, intrahepatic cholangiocarcinomas, and hematologic malignancies.

Azacitidine, also referred to as Vidaza or Onureg, is a chemotherapy drug used to treat chronic myelomonocytic leukaemia (CMML).

The presence of IDH2 mutation is linked to the development of low-grade astrocytomas and subsequent high-grade gliomas. This indicates that both IDH1 and IDH2 play a role in the production of D-2-hydroxyglutarate in cells. Additionally, mutations in IDH1 and IDH2 are frequently observed in normal karyotype acute myeloid leukemia.