J&J cancer med adds indication, lower dose

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J&J cancer med adds indication, lower dose
J&J cancer med adds indication, lower dose

Pharmacyclics and Johnson & Johnson biotech arm Janssen scored another approval for Imbruvica (ibrutinib) today, this one for second-line use in chronic lymphocytic leukemia (CLL). The drug was initially approved in November for mantle cell lymphoma (MCL). Treatment for CLL with Imbruvica will be cheaper than for MCL, due to a lower dosage (three pills daily vs. four).

CLL occurs when bone marrow creates too many lymphocytes—a type of white blood cell—and the disease is characterized by its slow progression in patients. The blood cancer is the second most common type of leukemia in adults, according to the National Cancer Institute. CLL is more prevalent in the middle-aged than in children.

Imbruvica had a smoother path than most for its original approval. The oral drug was the second ever to be fast-tracked and approved by FDA—it was given the green light in 4.5 months—and received "breakthrough" status, priority review, accelerated approval, as well as orphan-drug designation.

Lead investigator for the trial which formed the basis of the drug's approval, Dr. Arthur James, from Ohio State University, said, “CLL is a challenging disease and many patients switch their patients from therapy to therapy as their disease relapses. There has been a significant need for new alternatives for those patients."

The first breakthrough designee to be approved by FDA, coincidentally, is also indicated for CLL. Roche/Genentech's Gazya, approved in November of last year, is a first-line infusion treatment for CLL. First Word Pharma reported last year that Genentech estimated a course of treatment for Gazyva to run $41,300.

Janssen spokesperson Kellie McLaughlin told MM&M that the US wholesale price of Imbruvica for CLL will run $8,200 for a 30-day, 90-capsule bottle. Patients are instructed to take three pills a day. Median treatment duration in trials were about 15 months, which would run about $123,000. The drug's label, though, does not have an established duration of response for CLL.

That price is still lower than for patients using Imbruvica to treat MCL. The Street reported last November that the drug would cost $130,000 for a year of treatment for MCL with Imbruvica. Although, MCL does require a higher dosage: four capsules per day as opposed to three in CLL. A month's supply for Imbruvica in MCL costs $10,933 for a 120-pill bottle in the US.

Imbruvica is currently being investigated in trials for use in refractory follicular lymphoma, small lymphocytic lymphoma, multiple myeloma (when paired with Amgen's Kyprolis), among other areas.

Correction: There is no established duration of response for CLL on Imbruvica's label.
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