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Imbruvica gains expanded use in Europe

Rival Calquence receives accelerated review in US

Imbruvica

AbbVie and Janssen’s Imbruvica (ibrutinib) has received approval from the European Commission (EC) for two expanded variations to broaden the use of the drug. 

The EC has approved the use of Imbruvica in combination with obinutuzumab (Gazyva, Roche) in adult patients with previously untreated chronic lymphocytic leukaemia (CLL) and in combination with rituximab (Rituxan, Roche) for the treatment of adult patients with Waldenström's macroglobulinemia (a type of lymphoma).

Imbruvica is a Bruton’s tyrosine kinase (BTK) inhibitor, which works by blocking BTK proteins to decrease the survival and migration of B lymphocytes, which in turn delays the progression of cancer.

It is currently approved in Europe for the treatment of CLL as a single agent or in combination for the treatment of adult patients who have received at least one prior therapy. It is also approved for use in mantle cell lymphoma (MCL) for the treatment of adult patients who have relapsed or refractory MCL.

“With five European Commission approvals in five years, this latest EC decision further extends the potential reach and impact ibrutinib can have for patients,” said Craig Tendler, vice president, clinical development and global medical affairs, oncology, Janssen Research & Development.

“We remain committed to a comprehensive clinical development programme for ibrutinib, including exploring its use in other combinations, to address the needs of more and more patients with B-cell malignancies,” he added.

Imbruvica has experienced some heated competition recently, with AstraZeneca revealing promising data in support of the use of its own BTK inhibitor in CLL. The drug, Calquence (acalabrutinib), was shown to significantly prolong the time relapsed or refractory CLL patients live without disease progression.

As of August 2019, it is looking even more likely to catch up to Imbruvica, with the FDA in the US granting Calquence Breakthrough Therapy Designation as a monotherapy treatment for CLL. This means that an accelerated regulatory review is on the horizon and the drug is well on its way to market approval.

However, Calquence does have some way to go to catch up to the blockbuster status of Imbruvica, which made $3.6bn in 2018 and has a target of $4.4bn this year. In comparison, Calquence made $62m last year, with most of those sales coming from the US.

Despite this, AZ is looking to continue to make gains on Abbvie and Janssen, with reported studies testing the efficacy of Calquence in multiple myeloma, Waldenström's macroglobulinemia and diffuse large B-cell lymphoma.

Article by
Lucy Parsons

14th August 2019

From: Regulatory

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