FDA Approves New Treatment Option for People Newly-Diagnosed With Acute Myeloid Leukemia
November 21st, 2018
On November 21, 2018, the FDA approved a Genentech medicine in combination with azacitidine, or decitabine, or low-dose cytarabine, for people newly-diagnosed with acute myeloid leukemia (AML) who are age 75 years or older, or who are ineligible for intensive chemotherapy due to coexisting medical conditions.
This indication is approved under accelerated approval based on response rates. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
News in brief
- This accelerated approval was based on results from the M14-358 study and the M14-387 study in people newly-diagnosed with AML including those who were ineligible for intensive induction chemotherapy.
- AML is the most common type of aggressive leukemia in adults and has the lowest survival rate for all types of leukemias, and nearly 20,000 people will be diagnosed with the disease in the U.S. this year.
- Many people with AML are unable to tolerate intensive induction chemotherapy. Venclexta represents a new treatment option for people with AML regardless of subtypes.
Supporting Information
"Today’s approval marks a significant advance for people with acute myeloid leukemia, a highly aggressive and difficult-to-treat blood cancer. Many people with acute myeloid leukemia are unable to tolerate standard intensive chemotherapy, and the Venclexta combination regimens represent important new options for these patients.”