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AstraZeneca's (AZN) Tagrisso sNDA Receives Priority Review

Zacks Equity Research
·3 min read

AstraZeneca PLC AZN announced that the FDA has accepted and granted priority review to its supplemental new drug application (sNDA) seeking label expansion of its blockbuster lung cancer medicine Tagrisso AstraZeneca’s sNDA seeks to expand Tagrisso’s label for adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumor resection with curative intent.

A regulatory decision on the sNDA is expected in the first quarter of 2021. The drug enjoys Breakthrough Therapy Designation for this indication.

The sNDA was filed by the company based on data from the phase III ADAURA study, which evaluated 80mg once-daily oral administration of Tagrisso for three years or until disease recurrence. Data from the study demonstrated that treatment with Tagrisso achieved a statistically significant and clinically meaningful improvement in disease-free survival.

This year so far, AstraZeneca’s shares have risen 4.7% against a decrease of 2.5% for the industry.

We remind investors that Tagrisso is already approved as a treatment for first-line EGFRm advanced NSCLC and EGFR T790M mutation-positive advanced NSCLC in several countries. Quarterly sales of the drug crossed the billion-dollar mark for the first time in the second quarter of 2020, reflecting a 35% year over year increase. The strong growth was driven by continued demand growth in the second-line setting and strong uptake in the first-line setting as a NSCLC treatment.

Per the press release, while up to 30% of all patients with NSCLC may be diagnosed early enough to have potentially curative surgery, the majority of patients experience recurrence within five years. A potential approval to the latest Tagrisso sNDA will likely further boost sales of this drug by making the drug eligible for an expanded patient population.

AstraZeneca has a strong portfolio of cancer drugs, which is the major revenue generating segment for the company. Sales from the oncology segment was $5.3 billion in the first half of 2020. Apart from Tagrisso, other key cancer drugs include Imfinzi and Lynparza. Imfinzi is approved for treating NSCLC and advanced bladder cancer in second-line settings. AstraZeneca markets Lynparza in partnership with Merck MRK, which was already approved for treating ovarian, breast and pancreatic. In May, the drug received approval for treating HRR gene-mutated metastatic castration-resistant prostate cancer. It was also approved as first-line maintenance treatment in combination with Roche’s RHHBY Avastin (bevacizumab) for HRD-positive advanced ovarian cancer in the same month.

AstraZeneca PLC Price

AstraZeneca PLC Price
AstraZeneca PLC Price

AstraZeneca PLC price | AstraZeneca PLC Quote

Zacks Rank and Stock to Consider

AstraZeneca currently carries a Zacks Rank #3 (Hold).

Vertex Pharmaceuticals VRTX is a better-ranked large biotech stock, carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Vertex’s earnings estimates have moved 1.3% north for 2020 and 1.7% for 2021 over the past 30 days.

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AstraZeneca PLC (AZN) : Free Stock Analysis Report
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