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NCCN recommends Brukinsa for CLL/SLL even though it is FDA-approved for mantel cell lymphoma.
Chronic lymphocytic leukemia (CLL) is the most common type of leukemia that affects adults, accounting for about 40% of all leukemia diagnoses among adults in the U.S. adults. The median age of diagnosis is 70.Roughly 21,000 people in the U.S. are diagnosed with CLL each year, and about 4,300 will die from the disease, although the number of deaths has been dropping.
Here are three recent developments in CLL:
The December 2020 NCCN guidelines recommended Brukinsa (zanubrutinib) as a first-and second-line treatment for CLL/SLL. This is noteworthy partly because Brukinsa is approved for mantle cell lymphoma, not for CLL/SLL.The NCCN recommendations were based on positive results from the arm C, phase 3 SEQUOIA Trial demonstrating that treatment with the drug resulted in an overall response rate of 94.5% and was well tolerated. BeiGene, the manufacturer of Brukinsa, recently announced positive results from the planned interim analysis of the ongoing phase 3 ALPINE trial. Brukinsa met the primary endpoint of showing noninferiority in objective response rate (ORR) compared with Imbruvia (ibrutinib), an FDA-approved treatment for CLL. Brukinsa also met the secondary endpoint of safety, which demonstrated it had a statistically significant lower risk of atrial fibrillation or flutter compared with ibrutinib.
A study in Israel evaluated the antibody response that people with CLL/SLL have in response to Pfizer COVID-19 vaccine compared with healthy individuals. Blood serum of all study participants were collected two to three weeks after administration of the second vaccine dose. There were 167 patients in the CLL/SLL group and 52 participants in the control group. Antibody-mediated response to the vaccine occurred in 66 of 167 (39.5%) of all patients with CLL. A comparison between 52 patients with CLL and the same number of sex- and aged-matched healthy controls showed that the CLL patients had a significantly reduced response rate (52% for the CLL patient versus 100% for the control group).
But the antibody response rate varied among CLL patients: Those in active treatment had the lowest response and people in clinical remission, the highest. Further studies are needed to assess vaccine efficacy in CLL patients against COVID-19, although there is wide agreement that vaccination is critically important for patients with CLL because of evidence that they are high risk for developing severe COVID-19. The CDC’s mask recommendations mention the limited evidence about the efficacy of the vaccines in immunocompromised patients. People with CLL that are fully vaccinated may still want to wear mask for added protection..
The FDA has accepted the BLA for TG Therapeutics’ investigational novel drug ublituximab in combination with Ukoniq (umbralisib) as a treatment for patients with CLL and SLL with a PDUFA goal date of March 25, 2022.This is based on positive results from the global phase 3 UNITY-CLL trial.The combination treatment was previously granted Fast Track and orphan drug designations for CLL.