Advise women of the potential risk to a fetus.It is not known if CALQUENCE is present in human milk. A total of 535 patients were randomized 1:1:1 between the 3 treatment arms.The primary end point of the trial was progression-free survival (PFS) and secondary end points included objective response rate (ORR), time to next treatment (TTNT), overall survival (OS), and adverse events.According to a press release from AstraZeneca, the developer of the BTK inhibitor, in June, the trial met its primary end point as of the interim analysis.The hazard ratio for PFS for the acalabrutinib and obinutuzumab arm compared with the obinutuzumab and chlorambucil arm was 0.10 (95% CI, 0.006-0.17;ASCEND is an international, multicenter, open-label, phase III trial that investigated the use of single-agent acalabrutinib compared with rituximab (Rituxan) and either idelalisib (Zydelig) or bendamustine in patients with relapsed or refractory CLL (NCT02970318).The trial enrolled 310 patients who were randomized 1:1 to receive 100 mg of acalabrutinib twice daily or one of the combination regimens.
As of the meeting, the acalabrutinib arm had not yet reached a median PFS compared with 16.5 months in the rituximab-based combination therapy arm (HR, 0.31; 95% CI, 0.20-0.49; The ORR by IRC assessment in the acalabrutinib arm was 81% (95% CI, 74%-87%) compared with 76% (95% CI, 68%-82%) with rituximab/idelalisib or rituximab/bendamustine (At a median follow-up of 16.1 months, the OS had not yet been reached in either treatment arm (HR, 0.84; 95% CI, 0.42-1.66;Treatment discontinuation due to adverse events (AEs) was observed in 11% of patients in the acalabrutinib arm; 49% of patients receiving rituximab and idelalisib and 17% receiving rituximab and bendamustine also discontinued due to AEs.

Serious AEs were observed in 29%, 56%, and 26% of patients receiving acalabrutinib, rituximab/idelalisib, and rituximab/bendamustine, respectively. On November 21, 2019, the Food and Drug Administration approved acalabrutinib (CALQUENCE, AstraZeneca) for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). 2017 remains a banner year for B cell lymphomas and chronic lymphocytic leukemia (CLL) is a B cell lymphoma.The good news continued today with the approval of acalabrutinib, now known by the brand name CALQUENCE, for Mantle Cell Lymphoma (MCL).Acalabrutinib (formerly ACP-196) is similar to ibrutinib in that it blocks  BTK, a pathway critical for B cell survival.While ibrutinib has proven to be very effective in CLL, the most common reason patients discontinue therapy is intolerance. Infections due to hepatitis B virus (HBV) reactivation and progressive multifocal leukoencephalopathy (PML) have occurred.Monitor patients for signs and symptoms of infection and treat as medically appropriate. On 21 November 2019, the US Food and Drug Administration (FDA) approved acalabrutinib (CALQUENCE, AstraZeneca) for adults with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL). AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Calquence (acalabrutinib) for adult patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL).
Advise protection from sun exposure.In the combined safety database of 612 patients with hematologic malignancies treated with CALQUENCE monotherapy, atrial fibrillation and atrial flutter of any grade occurred in 3% of patients, and Grade 3 in 1% of patients. Monitor complete blood counts monthly during treatment.Second primary malignancies, including non-skin carcinomas, have occurred in 11% of patients with hematologic malignancies treated with CALQUENCE monotherapy in the combined safety database of 612 patients. Grade 3 or higher infections occurred in 18% of these patients.

Richter transformation occurred in 4 patients in the acalabrutinib arm and in 5 patients in the rituximab-based therapy arm.At least 1 AE of any grade was observed in 94% of patients in the acalabrutinib arm and in 99% and 80% of patients receiving the idelalisib and bendamustine combinations, respectively. 1 The US approval was granted under the FDA’s Real-Time Oncology Review and newly established Project Orbis programmes.. Acalabrutinib may have a different side effect profile and so the hope is that patients who can’t tolerate ibrutinib, but for whom it is working, might be able to better tolerate acalabrutinib and get similar benefits. The FDA today approved acalabrutinib as initial or subsequent therapy for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma. A number of therapeutic options have become available in the frontline setting for patients with chronic lymphocytic leukemia, most recently the second-generation BTK inhibitor acalabrutinib.

“We are pleased to continue working alongside our Australian and Canadian colleagues to facilitate new treatment options for patients and the FDA looks forward to working with other countries in future application reviews.”The supplemental approval for acalabrutinib in CLL/SLL was supported by findings from 2 randomized phase III clinical trials: ELEVATE-TN and ASCEND.ELEVATE-TN (ACE-CL-007) is a multicenter, open-label phase III trial that investigated the combination of acalabrutinib and obinutuzumab (Gazyva) versus obinutuzumab and chlorambucil chemotherapy or acalabrutinib monotherapy in patients with newly diagnosed CLL (NCT02475681).


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