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Clock starts ticking on FDA review of AZ's acalabrutinib

If approved, the BTK inhibitor could achieve annual peak sales of $5bn


The FDA has started its review of AstraZeneca's BTK inhibitor acalabrutinib, shortly after granting the drug a breakthrough designation for relapsed or refractory mantle cell lymphoma (MCL).

The US regulator has also awarded acalabrutinib a priority review, setting up a possible approval for the drug - which is a rival to Johnson & Johnson/AbbVie's big-selling Imbruvica (ibrutinib) - in the first quarter of 2018.

The marketing application is based on the results of the phase II ACE-LY-004 clinical trial, involving MCL patients whose cancer has deteriorated after or failed to respond to prior treatment for the disease.

AZ picked up rights to acalabrutinib when it took control of Acerta Pharma in 2015, buying a majority stake in the Dutch biotech in a deal valued at up to $7bn. The BTK inhibitor is designed to interrupt the signalling process that B-cell cancers use to proliferate.

The company has previously said it believes acalabrutinib may have an advantage over ibrutinib because it is more selective - specifically the latter also inhibits other kinases, which make it more likely to cause side effects - and suggested that its drug could achieve annual peak sales in the region of $5bn.

"We believe acalabrutinib has the potential to be a very important treatment option for patients with this life-threatening blood cancer," said Flavia Borellini, Acerta's chief executive.

"The FDA's NDA acceptance exemplifies our progress in the acalabrutinib development programme and continues our momentum as we seek to transform care for people with haematologic malignancies," he added.

If approved, acalabrutinib would have the task of taking on Imbruvica, which had sales of more than $2.2bn last year in its approved indications - chronic lymphocytic leukaemia (CLL), Waldenström's macroglobulinemia (WM), marginal zone lymphoma (MZL) and MCL - and according to EvaluatePharma (EP) is due to reach $7.5bn in global sales by 2022, elevating it into the top 10 pharma products in that year.

EP counts acalabrutinib as a key cancer pipeline drug for AZ - along with PD-L1 inhibitor Imfinzi (durvalumab) and CTLA4 inhibitor tremelimumab - that will reinforce its existing growth franchise of PARP inhibitor Lynparza (olaparib) and EGFR inhibitor Tagrisso (osimertinib).

The BTK inhibitor could play an even more important role for AZ in the wake of disappointing data for Imfinzi and Imfinzi plus tremelimumab in the MYSTIC study reported last week.

Article by
Phil Taylor

2nd August 2017

From: Regulatory



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