Pharmaceutical Approval Update: Nelarabine (Arranon) Injection

Nelarabine (Arranon) Injection

Manufacturer: GlaxoSmithKline, Inc., Research Triangle Park, NC

Indication: Nelarabine is indicated for the treatment of adults and children with T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL). It is used when the disease has not responded to or has returned after at least two chemotherapy regimens.

Biological Class: Nelarabine is a water-soluble pro-drug of the cytotoxic deoxyguanosine analogue, 9-p-D-arabino-furanosylguanine (ara-G) with T-cell selectivity. Nelarabine is demethylated by adenosine deaminase (ADA) to ara-G, mono-phosphorylated by deoxyguanosine kinase and deoxycytidine kinase, and subsequently converted to the active 5′-triphos-phate, ara-GTP. Accumulation of ara-GTP in leukemic blasts allows for incorporation into DNA, leading to inhibition of DNA synthesis and cell death. cialis canadian pharmacy

Uniqueness of Product: Nelarabine is a cancer chemotherapy drug that kills cancer cells by blocking the cell’s ability to reproduce. Rapidly dividing cancer cells are more sensitive to cancer chemotherapy drugs than the more slowly dividing normal cells.

Nelarabine was approved under the FDA’s accelerated approval program, which allows FDA to approve products for cancer and other serious or life-threatening diseases based on early evidence of a product’s effectiveness. In this case, this evidence consisted of the complete disappearance of cancer cells in some patients. In most cases, however, the cancer later returned. For patients who responded to nelarabine, the disappearance of cancer cells was sometimes accompanied by a return of normal blood cell counts.

Warnings: Nelarabine Injection should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. This product is intended for intravenous (IV) use only.
Neurological Events: Severe neurological events have included altered mental states such as severe somnolence; central nervous system (CNS) effects (e.g., convulsions); and peripheral neuropathy ranging from numbness and pares-thesias to motor weakness and paralysis. There have also been reports of events associated with demyelination, and ascending peripheral neuropathies similar in appearance to Guillain-Barre syndrome. Full recovery from these events has not always occurred with cessation of therapy with nelarabine. Close monitoring for neurological events is strongly recommended. Nelarabine should be discontinued for neurological events that have the National Cancer Institute’s Common Toxicity Criteria of grade 2 or greater.

Precautions:

Hematological: Leukopenia, thrombocytopenia, anemia, and neutropenia, including febrile neutropenia, have been associated with nelarabine therapy. Complete blood counts, including platelets, should be monitored regularly.

General: Patients receiving nelarabine should receive IV hydration according to standard medical practice for the management of hyperuricemia in patients at risk for tumor lysis syndrome. The use of allopurinol should be considered for patients at risk of hyperuricemia. Administration of live vaccines to immunocompromised patients should be avoided. tadalis sx

Dosage and Administration: The recommended adult dose of nelarabine is 1,500 mg/m2 administered intravenously and undiluted over two hours on the first, third, and fifth days and repeated every 21 days. The recommended pediatric dose is 650 mg/m2 administered intravenously and undiluted over one hour daily for five consecutive days repeated every 21 days.

Commentary: Each year, T-ALL or T-LBL is diagnosed in approximately 1,600 adults and children in the U.S. A subset of these patients experience relapse or develop disease that is refractory to treatment. There is no standard of treatment for these patients, and their prognosis is poor.

The FDA’s accelerated approval of nelarabine was granted on the basis of complete response rates shown in two phase 2 trials in patients who had exhausted standard treatment options. Postmarketing evaluation to verify and describe the product’s clinical benefit is planned through a randomized, multicenter phase 3 trial. Nelarabine represents new hope for adults and children with these rare and deadly cancers.
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Category: Drugs

Tags: Erlotinib, Nelarabine, Xyrem

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