- AbbVie and Johnson & Johnson's blood cancer medicine Imbruvica secured a broadened indication Monday, as the Food and Drug Administration OK'd a new, chemotherapy-free combination for frontline treatment of a common type of leukemia.
- The new approval covers treatment in combination with Roche's Gazyva for adults with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma. Results from a Phase 3 study published in December showed the combo reduced the risk of disease progression or death by 77% compared to the chemotherapy chlorambucil plus Gazyva in first-line CLL and SLL.
- Imbruvica was already approved in first-line CLL and SLL, both as monotherapy and together with chemotherapy and Rituxan. This label extension, though, is expected to fuel further sales growth of multi-billion dollar therapy. Last week, AbbVie reported global revenues from Imbruvica of $3.6 billion for 2018 and expects that figure to reach $4.4 billion this year.
Imbruvica (ibrutinib) is a key element in AbbVie's plans to move beyond Humira (adalimumab). As Humira, the world's top-selling drug, faces biosimilar competition in Europe and looming U.S. copycats beginning in 2023, the biopharma has struggled to convince investors of a clear path to growth.
On a Jan. 25 call discussing 2018 financial results, AbbVie execs highlighted Imbruvica's growth, calling it largely driven by the frontline CLL segment — now bolstered by this label expansion. This new OK will be the first chemotherapy-free, anti-CD20 first-line combo for CLL and SLL.
Recent data from three Phase 3 studies, including the trial that underpinned this approval, are expected to boost Imbruvica's share in frontline CLL from about 40% to upward of 70%, Leerink analyst Geoffrey Porges wrote last November after study results were announced at the American Society of Hematology's annual meeting.
The analyst argued the three studies together "effectively make ibrutinib a preferred regimen in 100% of CLL patients." Porges estimated the CLL market makes up about two-thirds of Imbruvica's sales already.
Yet while multiple Wall Street analysts have pegged peak annual sales of Imbruvica growing to $7 billion or higher within the next few years, AbbVie has struggled to soothe investors' broader concerns.
Credit Suisse, for instance, reiterated its underperform rating on the drugmaker Monday, citing multiple pressure points largely surrounding Humira. Compared to a year ago, fourth quarter revenue for the anti-TNF inhibitor was up less than 1%.
The biopharma's share price tumbled 6% Friday and dropped another 4% in Monday morning trading, dipping below $80 per share. The stock is down by one-third from a year ago, when AbbVie shares were trading for about $120.
Even Imbruvica's potential has its limits for AbbVie. Via a collaboration with Johnson & Johnson, the pharma giants split profits for the cancer drug and J&J owns exclusive ex-U.S. commercialization rights.
J&J's take from U.S. profits of Imbruvica has steadily grown, rising from about $300 million in 2015 to more than $1 billion in 2017, according to an annual report from AbbVie.
Outside of CLL, the therapy fell short in a recent Phase 3 study in pancreatic cancer, failing to beat a placebo arm in improving progression-free survival or overall survival.
Phase 3 readouts in relapsed or refractory follicular lymphoma, marginal zone lymphoma and mantle cell lymphoma are expected in late 2019 or early 2020.