OR WAIT null SECS
The clinical trials that supported the FDA decision, SEQUOIA and ALPINE, evaluated the efficacy of zanubrutinib and findings paved the way to add the therapy as a treatment option.
Zanubrutinib (Brukinsa) was approved by the FDA to treat patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The chemotherapy treatment was investigated in 2 separate clinical trials that provided the data which supported the agency's decision.
In an interview with HCPLive, Ian W. Flinn, MD, PhD, Director, Lymphoma Research, Sarah Cannon Research Institute at Tennessee Oncology, began by characterizing chronic lymphocytic leukemia and small lymphocytic lymphoma, before sharing the significance of the data.
"Chronic lymphocytic leukemia and small lymphocytic lymphoma are indolent diseases that, generally can be watched, or observed without any therapy after the initial diagnosis," Flinn explained.
This isn't due to a lack of effective therapies, he emphasized, but because evidence has shown early intervention doesn't extend survival.
"The most common way people are diagnosed is that they see their primary care physician for health maintenance examination," he continued. "They have a CBC drawn, and they have an elevated absolute lymphocyte count, and so that leads to the diagnostic evaluation for chronic lymphocytic leukemia, and ultimately, the the diagnosis."
The trials, SEQUOIA and ALPINE, evaluated the efficacy of zanubrutinib in a few ways, and findings paved the way to add the therapy as a treatment option. Flinn found the ALPINE data particularly interestings.
"Alpine was a randomization between 2 of these BTK inhibitors, one being ibrutinib, it was the first drug in his class, and the other was zanubrutinib in the relapse setting," he said. "In this setting, I think it was kind of unexpected -there was a significant improvement in progression-free survival for those patients who received zanubrutinib over ibrutinib and so I would have expected they'd be roughly the same."