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AstraZeneca's (AZN) Enhertu sBLA Receives FDA Priority Tag

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AstraZeneca (AZN - Free Report) announced that the FDA has accepted and granted priority review to it and its Japan-based partner, Daiichi Sankyo’s supplemental biologics license application (sBLA) seeking approval for Enhertu in a lung cancer indication. The sBLA is seeking approval for Enhertu for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have a HER2 (ERBB2) mutation and who have received a prior systemic therapy

With the FDA granting priority review to the sBLA, a decision is expected during the third quarter of 2022. A similar application is also under review in Europe.

AstraZeneca’s stock is up 19.2% this year so far compared with an increase of 7.1% for the industry.

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The sBLA was based on data from the DESTINY-Lung01 phase III study in which Enhertu demonstrated a strong tumor response in more than half of the patients with previously treated HER2-mutant metastatic NSCLC. The confirmed objective response rate (ORR) was 54.9% while the median progression-free survival (PFS) was 8.2 months and the median overall survival (OS) was 17.8 months in patients treated with Enhertu.

We remind investors that the FDA had earlier granted Breakthrough Therapy Designation to Enhertu in this cancer type. There are currently no HER2-directed therapies approved specifically for the treatment of HER2-mutant NSCLC. Enhertu has the potential to become the new standard-of-care medicine for this patient population which accounts for approximately 2-4% of patients with non-squamous NSCLC.

Enhertu is presently approved for previously treated HER2-positive metastatic breast and HER2-positive metastatic gastric cancer. It is also being evaluated for other HER2-targetable cancers, including breast, gastric, lung and colorectal cancers.

Enhertu is part of AstraZeneca’s flourishing oncology portfolio. Other key oncology drugs in AstraZeneca’s portfolio are Imfinzi, Tagrisso and Lynparza. AstraZeneca markets Lynparza in partnership with Merck (MRK - Free Report) .

AstraZeneca & Merck’s Lynparza, is approved for four cancer types, ovarian, breast, prostate and pancreatic for various patient populations. It has been used to treat over 40,000 patients worldwide. AstraZeneca/Merck’s Lynparza is also being evaluated in an earlier-line setting for the approved cancer indications as well as some other cancer types.

The drug generated product sales of $2.35 for AstraZeneca in 2021, and alliance revenues of $989 million for Merck.

Zacks Rank and Stocks to Consider

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

Some better-ranked large drug/biotech stocks are Vertex Pharmaceuticals (VRTX - Free Report) and Eli Lilly (LLY - Free Report) , both with a Zacks Rank #2 (Buy).

Vertex Pharmaceuticals’ stock has risen 28.6% this year. Estimates for Vertex Pharmaceuticals’ 2022 earnings have gone up from $14.52 to $14.58 per share, while those for 2023 have increased from $15.31 to $15.37 per share over the past 30 days.

Vertex Pharmaceuticals’ earnings performance has been strong, with the company beating expectations in each of the last four quarters. Vertex Pharmaceuticals has a four-quarter earnings surprise of 10.01%, on average.

Lilly’s stock has risen 8% this year so far. Estimates for Lilly’s 2022 earnings have gone up from $8.71 to $8.78 while those for 2023 have increased from $9.78 to $9.90 per share over the past 30 days.

Lilly’s earnings performance has been rather weak with the company missing earnings expectations in each of the last four quarters. Lilly has a four-quarter negative earnings surprise of 3.92%, on average.

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