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AstraZeneca Gets FDA Nod for Calquence Line Extension in CLL

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AstraZeneca AZN announced that the FDA approved the label expansion of its BTK inhibitor, Calquence (acalabrutinib), as a treatment for adult patients with chronic lymphocytic leukemia (“CLL”) or small lymphocytic lymphoma (“SLL”). The approval was based on positive data from two phase III studies — ELEVATE-TN and ASCEND — wherein Calquence demonstrated superior progression-free survival (PFS) in both first-line and relapsed or refractory CLL.

Calquence is presently marketed for the treatment of relapsed or refractory mantle cell lymphoma. The company has plans to submit regulatory applications seeking a label expansion of the same to include CLL patients in Europe and Japan in the first half of 2020.

Shares of AstraZeneca have rallied 25.3% so far this year compared with the industry’s growth of 4.1%.

The ELEVATE-TN study evaluated Calquence monotherapy or in combination with Roche’s (RHHBY - Free Report) Gazyva (obinutuzumab) in first-line CLL patients. Data from the study showed that treatment with the drug alone or in combination has reduced the risk of disease progression or death by 80% and 90%, respectively, compared to chemotherapy, chlorambucil, in combination with Gazyva (standard-of-care medicines). The median time to disease progression in patients has not been reached yet for both monotherapy and the combo regimen versus 22.6 months for standard-of-care.

The ASCEND study compared Calquence monotherapy to a combination regimen of Roche/Biogen’s BIIB CD-20 antibody, Rituxan (rituximab), plus Gilead’s GILD Zydelig (idelalisib) or Teva’s Treanda (bendamustine) in previously treated CLL patients. Previously announced data showed that Calquence reduced the risk of disease progression by 69% compared to the Rituxan combination therapy after a median follow-up of 16.1 months. The median PFS for the drug is yet to be reached, while the same for the Rituxan combo is 16.5 months. Meanwhile, 88% of patients treated with Calquence did not show any disease progression at 12 months compared to 68% for the control arm.

The safety and tolerability profile for Calquence was consistent with its established profile in both clinical studies.

Calquence generated $108 million in the first nine months of 2019. With the approval for this much larger indication, AstraZeneca can gain access to a broader patient population and boost sales of this promising drug.

AstraZeneca has built a strong oncology portfolio, which includes Tagrisso, Imfinzi, Lynparza, Iressa, Calquence and other legacy drugs. Sales of this segment were 37% of the company’s total sales in the first nine months of 2019. Oncology sales were up 50% year over year in that period.

Zacks Rank

AstraZeneca currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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