Venclexta’s growth prospects
AbbVie (ABBV) and Roche Holdings (RHHBY) have strategized to position Venclexta as a foundation therapy in the chronic lymphocytic leukemia (or CLL) indication. That’s due to the drug’s robust responses in terms of progression-free survival, durability of response, and overall response rate.
Venclexta has already been approved in more than 45 countries for one CLL indication. It’s under regulatory review in an additional 40 countries. On April 11, 2016, the FDA (U.S. Food & Drug Administration) approved Venclexta as a second line plus therapy for patients suffering with CLL and have 17p deletion. The robust clinical profile of Venclexta is expected to drive awareness and the uptake of chemotherapy-free regimens in the CLL segment.
AbbVie accounts for 0.72% of the Vanguard S&P 500 ETF (VOO).
On September 18, 2017, AbbVie announced positive results from its Phase 3 MURANO trial that compared the efficacy of the combination regimen of Venclexta and Rituxan compared to the bendamustine-Rituxan regimen in patients suffering with relapsed/refractory CLL. On December 12, 2017, Roche Holdings announced that the Venclexta-Rituxan combination regimen reduced the risk of disease progression or death by 83% compared to the standard of care. AbbVie and Roche Holdings plan to submit an NDA (New Drug Application) to the FDA for Venclexta in this indication in the coming months. The companies plan to gradually expand Venclexta’s label in relapsed/refractory and then first line CLL indications. Venclexta is thus expected to enable AbbVie to pose strong competition for other CLL players such as Celgene (CELG) and Johnson & Johnson (JNJ).
AbbVie and Roche Holdings are also studying Venclexta in an ongoing Phase 3 program in the acute myeloid leukemia (or AML) indication. On July 28, 2017, Roche Holdings announced that the FDA had granted a breakthrough therapy designation for Venclexta in AML. Based on favorable data from the Phase 1B trial, Venclexta in combination with Takeda Pharmaceuticals’ Velcade and dexamethasone is currently being studied in a Phase 3 trial in the multiple myeloma indication. AbbVie also aims to expand Venclexta’s label in various non-Hodgkin’s lymphoma indications such as diffuse large B-cell lymphoma (or DLBCL), follicular lymphoma (or FL), and mantle cell lymphoma, either in combination with chemotherapy or non-chemotherapy agents.
In the next part, we’ll take a look at AbbVie’s solid tumor strategy.