Drug Development, FDA

Following PhIII breakdown, AstraZeneca cruises toward an FDA decision for its BTK blockbuster hopeful acalabrutinib

Just when AstraZeneca would prefer to turn away from its Phase III breakdown with durvalumab and tremelimumab, along comes acalabrutinib.

Yesterday, their BTK inhibitor was granted a breakthrough therapy designation at the FDA, and regulators immediately backed it up today with a priority review designation that will speed up the oversight process and quite likely offer another cancer drug approval sometime in January 2018.

Peak sales estimates for this drug scrape the $1 billion mark — earning it a spot on the top 10 orphan drugs in the late-stage pipeline, according to EvaluatePharma stats for 2022 — which would make it a valuable addition to the portfolio.

AstraZeneca paid $4 billion to buy a majority stake in Acerta less than 2 years ago just so the pharma giant could land this drug. At the time, CEO Pascal Soriot confidently predicted that the drug was a $5 billion annual earner in the making. And he was happy to say that would be on top of the $45 billion in 2023 revenue he had promised investors in his campaign to fend off a buyout attempt by Pfizer.

After a series of pratfalls in the clinic, though, it’s unlikely anyone in the company would be so bold with predictions like that again. Nevertheless, acalabrutinib remains a key part of its late-stage pipeline, and one of its best bet for some near-term good news on the drug approval front.

AstraZeneca lined up this application with Phase II data as a second-line therapy for relapsed/refractory mantle cell lymphoma, in keeping with the fast-forward strategy to accelerated approvals that the FDA has been encouraging.

AstraZeneca has pushed ahead on a slate of cancer drugs in some big fields, making this its one major bright spot as the company continues the years-long pursuit of a turnaround. Lynparza was the first PARP approved, and has moved along with significant new data over the last year. The pharma giant has built up some megablockbuster hopes for Tagrisso as well as Imfinzi (durvalumab) on the PD-L1 side.

Pascal Soriot’s big bet on leaping ahead on the checkpoint front with combos has run into a brick wall, for now, but the company retains blockbuster hopes that it can be turned around. Adding acalabrutinib and going after the Imbruvica (ibrutinib) franchise — the big cancer drug from J&J and AbbVie, would be a big help — and a welcome distraction.

Acerta CEO Flavia Borellini said: “We believe acalabrutinib has the potential to be a very important treatment option for patients with this life-threatening blood cancer. 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.”

Image: Pascal Soriot AP Images

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
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Catalytic Data Science Charleston, SC
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Flatiron Health New York City or San Francisco

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