AstraZeneca scores again: Calquence approved for CLL as BTK race heats up
Six months after first boasting about Phase III data, AstraZeneca has earned expanded FDA approval for its BTK inhibitor Calquence. The drug will now be used to treat one of the most common adult blood cancers, chronic lymphocytic leukemia (CLL).
In the spring, the European giant called its shot early, pointing toward regulatory submissions as interim trial data came out. They said in May the drug had aced a Phase III trial as a second-line CLL treatment. Then in June, they announced high progression-free survival from patients in a trial of patients who received Calquence as a frontline therapy.
The drug is now approved as a single agent and as a combination therapy for frontline and second-line treatment. The drug is also approved to treat SLL or small lymphocytic leukemia, which is the same disease as CLL but appears in the lymph nodes as opposed to blood or bone marrow. Previously, it was only approved for mantle cell lymphoma.
The ELEVATE-TN study on Calquence as a frontline treatment showed the drug lowered the risk of disease progression or death by 90% in combination with another therapy and by 80% as a monotherapy.
Despite Imfinzi’s continued stumbles, AstraZeneca’s oncology group has largely thrived under new chief José Baselga, who arrived at the pharma giant after a controversial exit at Memorial Sloan Kettering. In August, the company announced two more rounds of strong Phase III data from their PARP inhibitor Lynparza, first in prostate cancer and then in ovarian cancer.
Calquence is part of the next generation of BTK inhibitors that have promised to be safer and more tolerable to patients. These inhibitors block Bruton’s tyrosine kinase, an enzyme that plays a role in oncogenic signaling and the rise of some leukemic cells. J&J and AbbVie unveiled the first such drug, Imbruvica, in 2013, but despite billions in revenue, the drug can have steep side effects.
Earlier this month, the FDA approved BeiGene’s second-generation BTK inhibitor, Brukinsa, for mantle cell lymphoma. It was the first-ever Chinese cancer drug approved in the US.