FDA, New Products

AstraZeneca gets an early green light on BTK blockbuster hopeful Calquence

Image: Pascal Soriot AP Images


AstraZeneca $AZN has received an early OK from regulators to sell its cancer drug acalabrutinib, now under the brand name Calquence.

The BTK inhibitor — being set up as a rival to Imbruvica from AbbVie and J&J — is a treatment for cancer patients with mantle cell lymphoma, a rare B-cell non-Hodgkin lymphoma. The drug will be used as a second-line therapy for relapsed/refractory mantle cell lymphoma.

AstraZeneca had expected the FDA to make its decision sometime in Q1 of next year, but regulators were clearly ready to run on this one, two months after they handed the pharma giant a breakthrough drug designation to hurry it along.

A spokesperson for AstraZeneca tells Endpoints News the average monthly price for the drug in the US is set at $14,259, or $171,108 per year, which she adds “is on par with other currently marketed treatments in its class.”

“Mantle cell lymphoma is a particularly aggressive cancer,” said Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “For patients who have not responded to treatment or have relapsed, Calquence provides a new treatment option that has shown high rates of response for some patients in initial studies.”

AstraZeneca paid $7 billion to buy a majority stake in Acerta Pharma back in 2015 primarily so it could snag this drug for its portfolio. Peak sales for acalabrutinib have been estimated at the $1 billion mark, which would be a sizable contribution to the company’s income. Last year, the company brought in $23 billion in revenue.

The approval marks the latest oncology success for CEO Pascal Soriot, who has been pushing for a turnaround at the pharma giant. Key to that has been the approval of Lynparza and Tagrisso, as well as the more recent success it’s had with the checkpoint inhibitor Imfinzi. Adding a fourth drug to the cancer portfolio will buy Soriot some more time to make the case that the company can start adding revenue after years of falling numbers.

Leerink’s Seamus Fernandez gives AstraZeneca high marks for the early approval, with a label that compares well with the rival BTK drug Imbruvica already in the market. But he also wants to see more data before deciding how the drug will fare.

Overall, the efficacy and safety appears to compare favorably to JNJ/ABBV’s BTK inhibitor Imbruvica (ibrutinib), but we note this is based on a relatively small number of patients. Calquence is currently in several trials for a number of hematological malignancies, and we await data from ongoing Phase 3 trials (primary completion dates starting in 2019) in the much larger chronic lymphocytic leukemia (CLL) population to determine if the drug has lower rates of atrial fibrillation (AF), bleeding, and potentially Richter’s transformation than Imbruvica.

Calquence was approved using the FDA’s accelerated approval pathway — a shortcut for drugs meeting serious conditions with unmet medical needs. The FDA said further study is required to verify and describe the clinical benefits of Calquence. AstraZeneca is conducting that trial now, the FDA said.

Earlier this month, Retraction Watch reported that one piece of the preclinical puzzle for Calquence was fabricated by a researcher at Acerta. The case involved a mouse model of pancreatic cancer and an abstract that was produced in 2015.



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