This accelerated approval of acalabrutinib was based on data from a single-arm trial that included 124 patients with mantle cell lymphoma who had received at least one prior treatment.
Accelerated approval was granted today by the U.S. Food and Drug Administration (FDA) to Calquence (acalabrutinib) for the treatment of adults with mantle cell lymphoma (MCL) who have received at minimum one previous form of therapy.
Mantle cell is an aggressive, fast-growing non-Hodgkin lymphoma, a cancer of the lymph system.
The treatment has been approved under the FDA's accelerated approval pathway based on an overall response rate, which allows for earlier approval of medicines that treats serious conditions and fills an unmet medical need based on a surrogate endpoint. Some 81 percent of trial participants given the drug had a complete or partial response.
"For patients who have not responded to treatment or who have relapsed, Calquence provides a new treatment option that has shown high rates or response for some patients in initial studies", said Dr. Richard Pazdur, director of the agency's Oncology Center of Excellence.
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Similarly, bank lending inclusive of RRPs increased by 20.1 percent from 17.9 percent in the previous month. Domestic claims grew 16.1 percent, slower than the 16.9-percent increase in August.
In the ACE-LY-004 study, 124 patients with MCL received oral acalabrutinib at 100 mg twice daily. Those treated with a prior BTK inhibitor were excluded from the trial. The median time to best response was 1.9 months.
The most common adverse events (AEs) of any grade were anemia (46 percent), thrombocytopenia (44 percent), headache (39 percent), neutropenia (36 percent), diarrhea (31 percent), fatigue (28 percent), myalgia (21 percent) and bruising (21 percent), which is a known class effect for BTK inhibition. Most bruising events were grade 1 in severity (19%). The most common grade 3 or higher AEs were neutropenia (15 percent), thrombocytopenia (12 percent), anemia (10 percent) and diarrhea (3.2 percent).
The median duration of treatment with acalabrutinib was 16.6 months (range, 0.1-26.6), with 73.4% of patients receiving the medication for ≥6 months and 59.7% of patients on treatment for ≥1 year.
Continued approval for this may be dependent on the verification and description of clinical benefit in confirmatory trials.
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