FDA Greenlights Generic Leukemia Treatment

The FDA has approved Shorla Oncology’s generic nelarabine injection to treat adult and pediatric patients one year and older with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma. T-cell leukemia is an aggressive blood and bone marrow cancer that progresses quickly. While most leukemias target older people, T-cell leukemia is most common among children. The product is a generic of Novartis’s Arranon.

A spokesperson for Shorla said the company could not comment on wholesale acquisition cost at this time. In preparation for the immediate commercial launch of Nelarabine Injection, Shorla is working with its commercialization services partner, Eversana, which it announced August 2021.

A study published in the Journal of Clinical Oncology in 2019 demonstrated that the 5-year disease-free survival rates for patients with T-cell acute lymphoblastic leukemia randomly assigned to nelarabine and no nelarabine were 88.2% ± 2.4% and 82.1% ± 2.7%, respectively. Differences between disease-free survival in a four-arm comparison were significant. Patients treated with the best-performing arm, escalating-dose methotrexate without leucovorin rescue plus pegaspargase and nelarabine, had a 5-year DFS of 91%.

Sharon Cunningham

“Nelarabine Injection is a critical treatment for patients living with T-cell Leukemia, particularly for children with leukemia, and it is our hope that today’s approval addresses the clinical need in this patient community,” Sharon Cunningham, chief executive officer and co-founder of Shorla Oncology, said in a press release.

Other recent generic drug news includes:

• Accord Healthcare has launched lurasidone HCL tablets, a generic of Sunovion Pharma's Latuda and is being offered in 20mg, 40mg, 60mg, 80mg, and 120mg doses in 30-count bottles. Lurasidone is an oral, atypical antipsychotic, which is a first-line treatment option for the management of schizophrenia in adults and adolescents. Lurasidone rebalances dopamine and serotonin to improve thinking, mood, and behavior.
• Amneal Pharmaceuticals has announced the FDA has accepted its abbreviated new drug application (ANDA) for naloxone hydrochloride nasal spray, USP, 4mg, which is the generic version of Narcan and is used in the treatment of a known or suspected opioid overdose emergency.
• Endo International and its Par Pharmaceutical have begun shipping the first generic version of Allergan’s Pylera (bismuth subcitrate potassium, metronidazole, tetracycline hydrochloride) 140 mg, 125 mg and 125 mg capsules. The therapy is used to treat patients with Helicobacter pylori infection and duodenal ulcer disease.
• Glenmark Pharmaceuticals and Cediprof will distribute Cediprof's FDA-approved dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets 5 mg, 10 mg, 15 mg, 20 mg and 30 mg, the generic version of Adderall. Glenmark expects the product to be available in the second half of 2023. This product has long been on FDA’s shortage list.
• Teva and Natco launch additional strengths of the generic version of Revlimid (lenalidomide capsules), in 2.5 mg, and 20 mg strengths. Teva’s lenalidomide capsules are a prescription medicine used in adults for the treatment of multiple myeloma in combination with the medicine dexamethasone, certain myelodysplastic syndromes, and mantle cell lymphoma following specific prior treatment.
• Zydus has launched the first AB1-rated generic of Topiramate extended-release, the equivalent of Supernus’ Trokendi XR, which is used to prevent migraines. The generic is available in 25 mg, 50 mg, and 100 mg tablet.