Janssen/AbbVie drug approved in graft-versus-host disease

Janssen/AbbVie’s Imbruvica has gained its first use outside of blood cancer, after the FDA approved it for chronic graft-versus-host disease (cGVHD).

The decision further vindicates AbbVie’s $21 billion takeover of Pharmacyclics back in 2015, which gave it access to the drug.

Janssen, part of Johnson & Johnson, had been developing Imbruvica in partnership with Pharmacyclics and the takeover came as a surprise to many people watching the industry.

Many thought at the time that AbbVie had overpaid – but it looks like an increasingly wise investment as the drug is now approved in a range of uses, including chronic lymphocytic leukaemia (CLL) and mantle cell lymphoma.

AbbVie’s CEO Richard Gonzales expects Imbruvica to generate sales in the region of $7 billion a year and is currently bringing in around half a billion dollars per quarter, with sales steadily building.

The approval is based on results from an open-label, multi-centre, single-arm phase 1b/2 trial (PCYC-1129) evaluating the safety and efficacy of ibrutinib in 42 patients with cGVHD who failed first-line corticosteroid therapy and required additional therapy.

In the study population, the most common underlying malignancies leading to transplantation were acute lymphocytic leukaemia (ALL), acute myeloid leukaemia (AML) and CLL.

Results showed an overall response rate of 67%, with 21% of patients achieving complete responses, and 45% achieving partial responses.

The most common adverse events included fatigue, bruising and diarrhoea.

A potential rival to the Bruton’s kinase inhibitor is AstraZeneca's acalabrutinib, which, the company said last week, had been granted a fast review in relapsed/refractory mantle cell carcinoma.

The UK pharma is also hoping acalabrutinib will outperform Imbruvica in a late-stage trial comparing the two drugs in CLL.

Peter Lebowitz, Janssen’s global head of oncology, said: “We are very pleased to bring Imbruvica to physicians and patients battling chronic graft-versus-host-disease.

“This indication for previously-treated cGVHD represents the first approved use of Imbruvica outside of the haematology-oncology category, and we are deeply proud of this development.”