FDA panel: Pharmacyclics' Imbruvica cancer data strong enough to unblind
- In a placebo-controlled study testing Imbruvica (ibrutinib) in combination with two other drugs (bendamustine and rituximab), the combo was successful versus placebo in previously treated patients with chronic lymphocytic leukemia or small lymphocytic leukemia.
- Imbruvica is already approved for four blood cancer-related indications, including treatment of CLL in patients who have already had at least one previous therapy.
- Pharmacyclics recently agreed to be acquired by AbbVie for $21 billion.
Imbruvica has proven to be a powerhouse oncology therapy for treatment of various blood cancers, including not only CLL, but also mantle cell leukemia and Waldenström's macroglobulinemia (WM).
The latest study, which included 578 patients, was sufficiently compelling to send Pharmacyclics' stock up 0.7% on Monday and AbbVie's stock up 2%.
Analysts have predicted roughly $1 billion in sales for Imbruvica this calendar year, with worldwide sales expected to hit $5.8 billion by 2020.