A supplemental New Drug Application (sNDA) has been filed with the U.S. Food and Drug Administration (FDA) for Venclexta® (venetoclax) in combination with a hypomethylating agent (HMA) or in combination with low-dose cytarabine (LDAC) for the treatment of newly diagnosed patients with acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. The sNDA submission is based on investigational data from two studies: M14-358, a Phase 1b trial evaluating venclexta in combination with an HMA (azacitidine or decitabine), and M14-387, a Phase 1/2 trial of venclexta in combination with LDAC.
About Acute myeloid leukemia (AML)
Acute myeloid leukemia is diagnosed in approximately 20,000 individuals each year in the United States. It is an aggressive leukemia, with the lowest survival rates of any acute leukemias. AML prevents certain immune cells from developing properly, leaving them in immature stages. These cancerous cells, referred to as “blasts”, are not able to fight infection as intended, and rapidly accumulate in the body. This crowds out other blood cells so that they are not able to carry out their essential functions.
With currently available treatments approximately 27 percent of patients diagnosed with AML will survive five years or more. Disease recurrence occurs in most patients within three years of diagnosis. Older individuals diagnosed with AML fare worse and only about one-third of those older than age 60 are able to tolerate the intensive chemotherapy required to achieve optimal results.1-5
About Venclexta® (venetoclax)
The BCL-2 (B-cell lymphoma 2) protein is a type of protein that is found in certain types of cancers that affect blood cells. This protein inhibits the death of cancer cells, enabling the cancer cells to grow and spread. Venclexta is an agent that inhibits the BCL-2 protein from protecting the survival of cancer cells, thereby resulting in reduced growth and/or the death of cancer cells.
Venclexta has been approved for treatment of certain leukemias and has now been granted Breakthrough Therapy Designations (BTDs) from the FDA for the combination of venclexta with an HMA (azacitidine or decitabine) for treatment-naïve patients with AML who are ineligible to receive standard induction therapy and for the combination of venclexta with lower dose Ara-C for treatment-naïve patients with AML who are ineligible for intensive chemotherapy.
1 Döhner H, et al. Acute myeloid leukemia. N Engl J Med. 2015;373(12):1136-1152.
2 National Cancer Institute (2018). Adult Acute Myeloid Leukemia Treatment (PDQ®)–Patient Version. https://www.cancer.gov/types/leukemia/patient/adult-aml-treatment-pdq. Accessed July 2018.
3 National Cancer Institute (2018). Acute Myeloid Leukemia – SEER Stat Fact Sheets. https://seer.cancer.gov/statfacts/html/amyl.html. Accessed July 2018.
4 Preisler HD, et al. The frequency of long-term remission in patients with acute myelogenous leukaemia treated with conventional maintenance chemotherapy: a study of 760 patients with a minimal follow-up time of 6 years. Br J Haematol. 1989; 71:189-194.
5 Schiffer CA, et al. Long-term follow-up of Cancer and Leukemia Group B studies in acute myeloid leukemia. Cancer. 1997; 80:2210-2214.
6 American Cancer Society (2018). Typical Treatment of Most Types of Acute Myeloid Leukemia (Except Acute Promyelocytic M3). https://www.cancer.org/cancer/acute-myeloid-leukemia/treating/typical-treatment-of-aml.html. Accessed July 2018.
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