AstraZeneca announced that the FDA expanded approval of the BTK inhibitor Calquence (acalabrutinib) to include use in adults with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL). The company noted that the clearance was granted under the agency's Real-Time Oncology Review and newly established Project Orbis programmes, with the latter involving collaboration with the Australian Therapeutic Goods Administration and Health Canada.
Dave Fredrickson, executive vice president of AstraZeneca's oncology business unit, said "the [CLL] patient population is known to face multiple comorbidities, and tolerability is a critical factor in their treatment." Results from the ELEVATE-TN study, which were used to support approval of Calquence, showed that adverse reactions leading to treatment discontinuation occurred in 11% of patients given the drug in combination with Roche's Gazyvaro (obinutuzumab), while a dose reduction of Calquence was required in 7% of subjects. Meanwhile, adverse reactions leading to treatment discontinuation occurred in 14% of patients in the control arm, who received chlorambucil plus Gazyvaro, with a dose reduction of chlorambucil needed in 28% of participants.
Interim data from the trial, along with the ASCEND study, showed that Calquence in combination with Gazyvaro or as a monotherapy significantly reduced the relative risk of disease progression or death versus the comparator arms in both first-line and relapsed or refractory CLL. In the ELEVATE-TN trial, the risk of disease progression or death was reduced by 90% in patients who received Calquence plus Gazyvaro, while in those given the BTK inhibitor alone, it was reduced by 80%. Results from the trial will be presented at the upcoming American Society of Hematology (ASH) congress.
In 2017, the FDA granted accelerated approval to Calquence for the treatment of adults with mantle cell lymphoma (MCL) who have received at least one prior therapy, with the drug carrying a monthly list price of around $14,260. AstraZeneca gained rights to Calquence as part of its $4-billion deal to acquire a majority stake in Acerta Pharma.
The expanded approval of Calquence comes shortly after the FDA authorised BeiGene's BTK inhibitor Brukinsa (zanubrutinib) to treat patients with relapsed and refractory MCL who have received at least one prior therapy. Meanwhile, in 2013, Johnson & Johnson and AbbVie's BTK inhibitor Imbruvica (ibrutinib) gained clearance in the US for patients with MCL who have received at least one prior therapy.
For related analysis, see ViewPoints: BeiGene's Brukinsa given official invite to Imbruvica-hunting party.
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