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AstraZeneca's Enhertu Gets Breakthrough Therapy Tag for NSCLC

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AstraZeneca PLC (AZN - Free Report) announced that the FDA has granted a Breakthrough Therapy Designation (BTD) to its antibody drug conjugate Enhertu for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a HER2 mutation and the disease has progressed on or after platinum-based therapy. The BTD was based on data from the registration phase II DESTINY-Lung01study.

The FDA’s Breakthrough Therapy tag is granted to expedite development and review of drugs that target serious or life-threatening conditions. The new medicine needs to have shown encouraging early clinical results that demonstrate a substantial improvement of a clinically significant endpoint over other approved medicines.

Notably, Enhertu was approved for HER2-positive metastatic breast cancer in December 2019.

This is the third BTD for Enhertu with the first BTD granted in 2017 for HER2-positive metastatic breast cancer. Earlier this month, Enhertu was granted the second BTD for HER2-positive metastatic gastric cancer. The BTD was based on data from the registration phase II DESTINY-Gastric01 study. Regulatory applications for third-line gastric cancer are expected to be filed in the second quarter of 2020.

In April 2019, AstraZeneca acquired the joint development and commercialization rights to this promising cancer candidate from Japan’s Daiichi Sankyo.

Shares of AstraZeneca have increased 7.2% in the year so far against the industry’s decrease of 1%.


In a separate press release, AstraZeneca announced that Bevespi Aerosphere, a has been approved by Chinese regulatory authorities as maintenance treatment to relieve symptoms in patients with chronic obstructive pulmonary disease (COPD) including those with chronic bronchitis and/or emphysema.

Bevespi Aerosphere is a fixed-dose, long-acting dual bronchodilator in a pressurised metered-dose inhaler device, which is already approved in the United States, the EU and across several other countries. It is a combination of glycopyrronium, a long-acting muscarinic antagonist (LAMA), and formoterol fumarate, a long-acting beta2-agonist (LABA).

The approval in China was based on positive data from the phase III PINNACLE 4 study.

Per the press release, this marks the first approval in China for a maintenance, fixed-dose, long-acting dual bronchodilator combination therapy in a pMDI, which uses the innovative Aerosphere delivery technology.

Notably, in December 2019, the National Medical Products Administration of China approved AstraZeneca’s Breztri Aerosphere, a triple combination therapy, (budesonide, glycopyrronium and formoterol fumarate), as a maintenance treatment for COPD.

However, competition remains stiff as Glaxo (GSK - Free Report) and its partner Innoviva, Inc. (INVA - Free Report) also have a triple combination drug (ICS/LAMA/LABA), Trelegy Ellipta, approved for COPD.

Zacks Rank & Another Key Pick

AstraZeneca currently carries a Zack Rank #2 (Buy). Another top-ranked stock in the large cap pharma sector is Eli Lilly and Company (LLY - Free Report) , which flaunts a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Eli Lilly’s shares have been revised 0.6% upward for 2020 and 1.1% for 2021 in the past 60 days. The stock has rallied 20.2% year to date.

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AstraZeneca PLC (AZN) - free report >>

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Innoviva, Inc. (INVA) - free report >>