FDA grants fast review to AZ cancer drug

Developed by Acerta Pharma, a haematology specialist in which AZ has a controlling interest, the FDA granted acalabrutinib a faster six-month review as opposed to the standard 10 month period.

The FDA will review acalabrutinib in patients with relapsed/refractory mantle cell lymphoma (MCL) who have received at least one prior therapy, and a regulatory decision is due in the first quarter of next year.

The FDA has also granted acalabrutinib a "Breakthrough Therapy" designation, indicating the regulator thinks the drug could bring an improvement in treatment for a serious disease.

Acalabrutinib is a Bruton tyrosine kinase (BTK) inhibitor and could compete against AbbVie/Janssen’s already approved Imbruvica (ibrutinib).

AstraZeneca is chasing the same indication after the failure of one of the two other approved drugs for MCL – Takeda’s Velcade or Celgene’s Revlimid.

The filing is based on phase 2 results from the ACE-LY-004 clinical trial, and detailed results are due to be presented at a forthcoming medical meeting.

AZ is developing acalabrutinib in a range of blood cancers and solid tumours, including in first-line treatment for patients with MCL.

According to Evaluate Pharma, AZ must find as many uses for the drug as possible if it is to recoup the $2.5 billion it paid for a controlling stake in US biotech Acerta Pharma in late 2015.

With sales of Imbruvica forecast to reach $8.4 billion in 2022, and only $875 million forecast for acalabrutinib that year, it looks like AZ will struggle to recoup its investment.

AZ’s share price has taken a beating over the last few days following the failure of the MYSTIC trial, which tested its cancer immunotherapy combination, Imfinzi (durvalumab) and tremelimumab, in the highly lucrative first-line lung cancer indication.

But since then the company has said Imfinzi has been granted Breakthrough Status as monotherapy by the FDA, as it seeks to develop a new generation of drugs to replace off-patent former blockbusters such as Crestor and Seroquel XR.

Imfinzi is a vital part of AZ’s plans to recover sales – when he successfully fought off a takeover bid from Pfizer in 2014, CEO Pascal Soriot set a sales target of $45 billion by 2023.

Pfizer itself is also struggling to make headway and CEO Ian Read this week ruled out any further big merger attempts until it has clarity on how the Trump administration plans to reform taxes.

Pfizer had been linked with a merger with Bristol-Myers Squibb, whose shares also tanked after the failure of immunotherapy Opdivo in first-line lung cancer last year.