First Generic to Sprycel Launched

Apotex has released generic dasatinib oral tablets in the United States, offering 20mg, 50mg, 70mg, and 100mg versions. This is the first generic to the tyrosine kinase inhibitor (TKI), Sprycel^® (dasatinib – Bristol Myers Squibb), which works by blocking the overproduction of leukemia cells, allowing normal red cells, white cells, and platelets to resume production. Sprycel was originally approved by the U.S. Food and Drug Administration (FDA) in 2006 for treating chronic myeloid leukemia (CML). Since its original approval, there have been several expansions for its indications as TKIs have helped transform CML from a fatal disease to a chronic illness that can be managed. Although approved in June 2016, Apotex launched its generic on Sept. 4, 2024, with 180 days of generic exclusivity. Bristol Myers Squibb estimated that U.S. sales for Sprycel amounted to $1.4 billion in 2023.

At a Glance

• Brand Drug: Sprycel(dasatinib)
• Generic Manufacturer: Apotex
• Launch Date: Sept. 4, 2024
• Indication: to treat newly diagnosed adults with Philadelphia chromosome-positive (Ph+) CML in chronic phase, adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib, adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy and pediatric patients one year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy (chemo) and Ph+ CML in chronic phase
• Dosage Forms Available: 20mg, 50mg, 70mg and 100mg oral tablets
• Annual U.S. Sales: $1.4 billion for 2023
• CML is a slowly progressing cancer of the blood and bone marrow that usually occurs during or after middle age and rarely occurs in children. The incidence of resistance increases with the number of years on treatment and severity of the disease. There are an estimated 9,280 new cases of CML diagnosed each year.
• ALL is a rapidly progressing cancer of the blood and bone marrow that occurs more commonly in children. Patients with advanced disease generally develop resistance more quickly than CML patients. An estimated 6,500 new cases of ALL are diagnosed each year.
• Most patients with CML have the Ph+ mutation, which causes the bone marrow to make an enzyme (tyrosine kinase) that destroys infection-fighting white blood cells. Around 3% of pediatric ALL cases involve the Ph+ subtype.
• The recommended dose for adults is 100mg for chronic phase CML and 140mg for all other adult conditions. For pediatric patients who weigh at least 45kg (about 100 pounds), the recommended dosing is 100mg per day. For patients who weigh less, doses are based on body weight. In clinical trials, tablets were dissolved in fruit juice or other liquids for patients who could not swallow whole tablets.
• The most common adverse effects associated with the use of dasatinib are fluid retention, gastrointestinal events (e.g. diarrhea, nausea and abdominal pain) and bleeding events (from low platelets). Bone growth should be monitored in pediatric patients due to reports of growth retardation. There is also risk of pulmonary arterial hypertension (PAH), a rare, but serious condition caused by high blood pressure in the arteries of the lungs. Over time, this can cause the heart muscle to become weak, resulting in shortness of breath, fatigue and swelling of the body. Patients and physicians should monitor for signs and symptoms of PAH prior to starting dasatinib and also during treatment. If PAH is confirmed, patients should discontinue dasatinib and the PAH should resolve.
• Other TKIs available to treat CML and ALL include Gleevec^® (imatinib – Novartis, generics), Tasigna^® (nilotinib – Novartis), Bosulif^® (bosutinib – Pfizer), Iclusig^® (ponatinib – Ariad) and Scemblix^® (asciminib – Novartis).