The acalabrutinib generic version launched by Lao Bear Pharmaceutical provides cancer patients worldwide with a new cost-effective treatment option besides the original drug.
Is there a generic version of Acalabrutinib available in Laos?
Yes, there is a generic version of Acalabrutinib in Laos. The Lao Bear version of Acalabrutinib is available in the specification of 100mg*60 capsules/box. For more information, it is recommended that you contact professional customer service for detailed consultation.
FDA Grants Accelerated Approval to Acalabrutinib for Relapsed or Refractory Mantle Cell Lymphoma
On October 31, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to acalabrutinib (generic name: acalabrutinib) for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. MCL is a rare and aggressive form of non-Hodgkin lymphoma, often diagnosed at an advanced stage, and most patients relapse after first-line treatment. This accelerated approval provides a new oral treatment option for MCL patients who have failed prior therapies. Acalabrutinib is a Bruton's tyrosine kinase (BTK) inhibitor that blocks the BTK signaling pathway to inhibit the proliferation and survival of B-cell tumors. The approval was primarily based on an open-label Phase 2 trial called LY-004 (NCT02213926), which enrolled 124 MCL patients who had received at least one prior therapy. The results showed an overall response rate (ORR) assessed by investigators of 81% (95% confidence interval: 73%, 87%), with a complete response rate of 40% (95% confidence interval: 31%, 49%). Of note, there was good agreement (91%) between the ORR assessed by investigators and that determined by an independent review committee. After a median follow-up of 15.2 months, the median duration of response had not been reached, while the median time to best response was only 1.9 months, indicating that most patients achieved tumor shrinkage shortly after starting treatment. Based on these encouraging data, the FDA granted accelerated approval to acalabrutinib and required continued verification of its clinical benefit.
Common Adverse Reactions of Acalabrutinib
In clinical trials of acalabrutinib, the most common adverse reactions reported in more than 20% of treated patients included: anemia, thrombocytopenia, headache, neutropenia, diarrhea, fatigue, myalgia, and bruising. Most of these adverse reactions were mild to moderate in severity, but close monitoring during treatment is still required. Notably, the percentage of patients who had a dose reduction due to adverse reactions was 1.6%, and the percentage of patients who discontinued treatment due to adverse reactions was 6.5%. The most common grade 3 or 4 adverse reactions (incidence ≥5%) were neutropenia, thrombocytopenia, and anemia. These hematologic abnormalities may increase the risk of infection and bleeding, so physicians should perform regular complete blood count monitoring. Acalabrutinib may also cause serious side effects that require high vigilance from patients and physicians. Bleeding events can occur during treatment and may be serious. The risk of bleeding is further increased if patients are taking blood thinners at the same time. Any signs or symptoms of bleeding, such as blood in the stool or black stools (looking like tar), pink or brown urine, unexpected bleeding or bleeding that does not stop, vomiting blood or vomit that looks like coffee grounds, coughing up blood or blood clots, dizziness, weakness, persistent headache, or voice changes, should be promptly reported to a physician. Additionally, infections can occur during acalabrutinib treatment; these infections may be serious and even lead to death. Patients should seek medical attention immediately if they experience fever, chills, or flu-like symptoms. Heart rhythm problems (atrial fibrillation and atrial flutter) have also been reported. Patients should inform their physician if they feel a fast or irregular heartbeat, dizziness, lightheadedness, fainting, shortness of breath, or chest discomfort.
