Acalabrutinib (Calquence, AstraZeneca) has been approved for two new indications — chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) — in three regions at the same time, by the United States Food and Drug Administration (FDA) in collaboration with the Australian Therapeutic Goods Administration and Health Canada.
The three authorities worked together as part of Project Orbis.
This is the second time the three regulatory authorities have collaborated on an approval for a new therapy. The first such approval, announced in September 2019, was for the use of a two-drug combination, lenvatinib (Lenvima, Eisai) together with pembrolizumab (Keytruda, Merck) for patients with advanced endometrial carcinoma.
"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," commented Richard Pazdur, MD, director of the FDA's Oncology Center of Excellence.
Its potential for use in the treatment of CLL was highlighted earlier this year at the European Hematology Association (EHA) 2019 Annual Meeting, where results from the phase 3 ASCEND trial were presented.
As reported by Medscape Medical News, the ASCEND trial was conducted in 310 patients with relapsed/refractory CLL assigned to receive acalabrutinib or physician's choice of either idelalisib with rituximab or bendamustine with rituximab. The results showed that acalabrutinib as monotherapy showed a significant improvement in tolerability as well as progression-free survival compared with standard treatment regimens.
"The ASCEND study demonstrated that acalabrutinib can provide a more effective and tolerable treatment option for patients with relapsed/refractory CLL compared to the standard combination therapies, including chemo-free approaches such as idelalisib plus rituximab," first author Paolo Ghia, MD, a professor of medical oncology at the Università Vita-Salute San Raffaele, Milan, Italy, told Medscape Medical News.
"These data may change the current practice of how we treat patients with relapsed or refractory disease," he said.
Acalabrutinib is a second-generation Bruton tyrosine kinase (BTK) inhibitor, which may have advantages over the first drug in this class, ibrutinib. Acalabrutinib is more selective for BTK with less off-target inhibition compared with ibrutinibin vitro, he added.
In its announcement, the FDA said that the new approval was based on data from the ASCEND trial as well as the ELEVATE-TN trial, conducted in 535 patients with previously untreated CLL that showed acalabrutinib improved progression-free survival compared with standard treatments. (Top-line results from ELEVATE-TN were announced in a company press release in June 2019.)
The agency also noted that the most common side effects of acalabrutinib were anemia, neutropenia, upper respiratory tract infection, thrombocytopenia, headache, diarrhea, and musculoskeletal pain.
It also noted that patients taking acalabrutinib may experience atrial fibrillation and flutter and should be monitored for symptoms of arrhythmias; may experience serious infections and should be monitored and treated promptly; and may experience bleeding and low blood counts and should be monitored regularly.
Patients should be advised to use sun protection as other malignancies, such as skin cancers and other solid tumors, have occurred in patients taking acalabrutinib. In addition, the FDA advises healthcare professionals to tell females of reproductive age to use effective contraception during treatment. Women who are pregnant or breastfeeding should not take the drug.
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Cite this: US, Australia, Canada Approve New Drug for Blood Cancers - Medscape - Nov 21, 2019.