AbbVie, Genentech to seek US approval of potential blockbuster leukemia med
- Pharma giants AbbVie and Roche/Genentech announced on Wednesday that their investigational leukemia drug venetoclax met primary endpoints in a phase II study of patients with chronic lymphocytic leukemia (CLL) who have a genetic mutation called a 17p deletion.
- CLL patients with the deletion have extremely poor prognoses and expected survival of just two to three years after diagnosis, which makes the possibility of an effective treatment for this form of leukemia particularly promising.
- In a phase II trial, venetoclax demonstrated a "meaningful reduction" in the number of cancer cells present in study participants, according to the companies. They will release the full data at an upcoming hematology meeting and plan to file the drug in the U.S. by the end of 2015.
"Approximately 30 to 50 percent of people with relapsed or refractory chronic lymphocytic leukemia have the 17p deletion that makes their disease difficult to treat," said Dr. Sandra Horning, chief medical officer and head of Global Product Development at Genentech, in a statement.
"Venetoclax may help restore the natural process that allows these leukemic cells to self destruct, representing a potential new way of helping people with this form of CLL who typically have a poor prognosis and limited treatment options."
Some analysts estimate that, if approved, the drug could bring in $2 billion in sales by 2020. The therapy already has the FDA's coveted "breakthrough" designation.