AbbVie has revealed plans to file its Roche-partnered experimental leukaemia drug venetoclax on both sides of the Atlantic on the back of promising Phase II data.
Specific results from the Phase II trial were not revealed, but the drugmaker said the primary endpoint of achieving overall response rates in patients with chronic lymphocytic leukemia (CLL) with 17p deletion were met.
Also, the safety profile was similar to previous studies and no unexpected safety signals were reported for the drug, AbbVie noted.
Around 3%-10% of CLL patients have 17p deletion at diagnosis, and it occurs in 30%-50% of patients with relapsed/refractory CLL. Unfortunately, the median life expectancy for those with this particular mutation is less than two-three years, highlighting the urgent need for new, effective therapies to improve the outlook.
Venetoclax was awarded breakthrough status in the US back in May, potentially speeding up its regulatory journey, and analysts are expecting the drug to attain blockbuster status if approved.
Full data from the trial is to be unveiled at a medical conference in the near future and will form the basis of applications to the health authorities around the globe.