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AstraZeneca Calquence Gets FDA's Breakthrough Status for CLL

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AstraZeneca AZN announced that the FDA has granted Breakthrough Therapy Designation (BTD) to its leukemia drug Calquence for chronic lymphocytic leukemia (CLL) as a monotherapy treatment. The BTD status was based on positive interim data from two phase III studies — ELEVATE-TN and ASCEND — on the BTK inhibitor. Data from the studies have shown that Calquence alone or as a combination therapy significantly increased the time patients lived without disease progression or death.

Calquence is presently marketed for the previously treated mantle cell lymphoma (MCL).  It is being developed in phase III programs for larger CLL indication and the company expects to file regulatory applications based on data from the ASCEND and ELEVATE-TN studies later this year to get an approval for CLL. If approved, this would definitely help AstraZeneca gain access to a broader patient population and boost sales of this promising drug.

Shares of AstraZeneca have rallied 16.3% this year so far against the industry’s decrease of 3.6%.



In a separate press release, AstraZeneca announced that the phase III study (PAOLA-1) evaluating its and Merck’s MRK PARP inhibitor, Lynparza, for a broader advanced ovarian cancer patient population met the primary endpoint. The study evaluated Lynpazra as a first-line maintenance treatment in combination with Roche’s RHHBY Avastin (bevacizumab) versus Avastin alone in women suffering advanced ovarian cancer with or without BRCA gene mutations. Data from the study showed that treatment with Lynparza plus Avastin led to a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) in the intent-to-treat (ITT) population versus Avastin alone.  Lynparza is presently approved as first-line maintenance treatment for BRCAm advanced ovarian cancer following response to platinum-based chemotherapy.

Lynparza, presently marketed for advanced ovarian cancer and breast cancer, is also in different studies for a range of tumor types including prostate, pancreatic and gastric cancers as well as earlier-line settings for ovarian and breast cancers.

Both Calquence and Lynparza are part of AstraZeneca’s strong oncology portfolio of drugs. Oncology sales now comprise around 35% of AstraZeneca’s total product sales, surging 50% in 2018 and 58% in the first half of 2019. In the same period, while Lynparza generated sales of $520 million, up 93% year over year, Calquence recorded revenues of $64 million.

Zacks Rank & Stock to Consider

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

A better-ranked large-cap pharma stock is Novartis NVS. Its earnings estimates for 2019 have inched up 2.8% while that for 2020 have been raised 2.3% over the past 30 days. Novartis stock has returned 3.3% so far in 2019.

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