FDA Grants Priority Review for Non-Small Cell Lung Cancer Drug

April 25, 2022 - The FDA recently granted priority review for AstraZeneca's Enhertu to treat adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have a HER2 mutation and have received prior systemic treatment therapy.  

AstraZeneca and Daiichi Sankyo jointly developed Enherty, a HER2-directed antibody– drug conjugate (ADC). Enhertu is the lead ADC in Daiichi Sankyo’s oncology portfolio and the most advanced program in AstraZeneca's ADC scientific platform. 

FDA based its decision on data from the DESTINY-Lung01 Phase 2 trial published in the New England Journal of Medicine and a Phase 1 trial published in Cancer Discovery.  

The DESTINY-Lung01 trial confirmed an objective response rate of 54.9% and a partial response rate of 53.8% in patients treated with Enhertu. Additionally, the confirmed disease control rate was 92.3% and a notable reduction in tumor size.  

After a 13.1-month follow-up, the median duration of response for Enhertu was 9.3 months, the median progression-free survival was 8.2 months, and the median overall survival was 17.8 months.  

The safety profile of the most common adverse events with Enhertu was consistent with previous clinical trials. And no new safety concerns were identified.  

"The DESTINY-Lung01 trial confirmed the HER2 mutation as an actionable biomarker in non-small cell lung cancer," Susan Galbraith, executive vice president of oncology research and development at AstraZeneca, said in the announcement.  

"If approved, Enhertu has the potential to become a new standard treatment in this patient population, offering a much-needed option for patients with HER2-mutant metastatic non-small cell lung cancer who currently have no targeted treatment options," Galbraith continued.  

So far, over 40 countries have approved Enhertu to treat adult patients with unresectable or metastatic HER2- positive breast cancer who received two or more prior anti-HER2-based regimens.  

Lung cancer is the second most common form of cancer globally, with more than two million new cases diagnosed in 2020.  The prognosis for patients with metastatic NSCLC is generally poor, as only about 8% will live beyond five years after diagnosis.  

In June 2021, FDA approved the first treatment for adult patients with NSCLC whose tumors have a specific type of genetic mutation and who received at least one prior systemic therapy.  

The agency approved Amgen's Lumakras for tumors with KRAS G12C, a type of mutation in a group of genes that help regulate cell growth and division. KRAS G12C mutations represent about 13% of mutations in NSCLC.