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AbbVie and J&J file first non-cancer use for Imbruvica with FDA

Seeks FDA approval to treat GVHD patients

AbbVie Johnson & Johnson Janssen Imbruvica

Johnson & Johnson and AbbVie have successfully added multiple new indications to blood cancer blockbuster Imbruvica, and are now pitching for the first use of the drug outside oncology.

The co-marketing partners have submitted Imbruvica (ibrutinib) to the FDA seeking approval as a second-line treatment for graft-versus-host-disease (GVHD), a serious and potentially life-threatening complication of stem cell or bone marrow transplant procedures.

BTK inhibitor Imbruvica has already been granted breakthrough and orphan status from the US regulator for this indication, setting the drug up for a speedy review. At the moment there are no FDA-approved medicines for patients who fail to respond to one or more lines of the usual systemic therapies for GVHD, which typically involves giving high-dose steroids on top of immunosuppressants like tacrolimus and cyclosporine.

The filing is based on data from a single-arm phase Ib/II trial that assessed Imbruvica in 42 patients in whom corticosteroid therapy had been unsuccessful. Adding a once-daily oral dose of AbbVie and J&J's drug resulted in one-third of patents achieving a complete response after 14 months, while 71% of patients had a sustained response lasting at least five months.

While Imbruvica's potential in blood cancer rests in its ability to modulate B cell receptor signalling, the drug also blocks interleukin-2 (IL-2) inducible T cell kinase, an enzyme expressed in T lymphocytes, and this is thought to be responsible for its immune-modulating effects in GVHD.

"Patients with chronic graft-versus-host-disease face an unpredictable, debilitating and sometimes life-threatening disease journey, which is further complicated by lack of FDA-approved medicines," commented Sen Zhuang, vice president of clinical development, haematology at J&J's Janssen R&D unit.

"We continue to study the mechanism of action of Imbruvica, and are committed to exploring its potential to transform treatment paradigms and patient outcomes beyond its current indications in blood cancers."

Imbruvica is already approved for chronic lymphocytic leukemia (CLL), previously treated mantle cell lymphoma (MCL), Waldenström macroglobulinaemia and marginal zone lymphoma (MZL), and is already a phenomenal success with AbbVie recording sales of $1.83bn last year and J&J booking another $1.25bn.

AbbVie has said it is targeting $7bn in peak sales for the drug – and the new indication could be another small step towards that ambitious goal, which would help justify the $21bn it paid to purchase ibrutinib's original developer Pharmacyclics in 2015.

The bulk of that potential increase will however depend on Imbruvica moving up the lines of treatment in haematological cancers, but claiming approval as a first-line treatment for GVHD would also help. AbbVie and J&J already have a phase III trial of the drug in new-onset GVHD which got underway last year and will compare ibrutinib plus prednisone to placebo plus prednisone.

Article by
Phil Taylor

5th April 2017

From: Regulatory

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