The U.S. Food and Drug Administration (FDA) has approved a new cancer treatment combining acalabrutinib (Calquence) and venetoclax for adults with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). This decision makes it the first all-oral, fixed-duration therapy available for patients who have not had prior treatment.
In the Phase III AMPLIFY trial, patients taking the Calquence-venetoclax combination for about 14 months showed better results compared with standard chemotherapy. After three years, 77% of people in the study had no disease progression, compared with 67% with traditional chemo options. The risk of disease getting worse or death was reduced by about 35%.
Doctors noted that this new combo allows patients to take pills rather than undergo typical chemotherapy infusions. Regulators already approved similar treatments in countries including the European Union, Canada and the UK.
For patients with CLL or SLL, this approval offers several important benefits like it will offer shorter fixed treatment as the therapy is given for a set period (around 14 months), unlike many leukemia treatments that continue indefinitely. It also gives compliance because it is an all-oral treatment that means patients can take tablets at home rather than visit clinics regularly for intravenous chemotherapy. Also, clinical data show patients may live longer without the disease worsening compared to older chemotherapy regimens.
For the general public, this approval shows progress in cancer care toward treatments that are more effective, more convenient and potentially easier to tolerate. It also reflects broader medical efforts to develop targeted therapies that can improve quality of life while fighting serious illnesses.
