Pfizer PFE has announced that the regulatory applications for its pipeline candidate, dacomitinib, have been accepted for review in both the United States and the EU. The company is looking to get the drug approved for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in patients with EGFR-activating mutations. Notably, the FDA granted a priority review to dacomitinib with a response expected in September 2018.
The regulatory submissions for dacomitinib were based on positive data from a global head-to-head phase III ARCHER 1050 study, evaluating dacomitinib (n=227) versus AstraZeneca’s
AZN lung cancer drug, Iressa (gefitinib), among patients with NSCLC. Data from the study demonstrated a median progression-free survival (PFS) of 14.7 months on treatment with dacomitinib compared with 9.2 months with Iressa, reflecting a reduction in the risk of disease progression by 41%.
However, 10% of patients treated with dacomitinib discontinued the study due to adverse events compared with 7% treated with Iressa. The company stated that a final assessment of overall survival from ARCHER 1050 study will be presented at a medical meeting later in 2018.
Shares of Pfizer were up almost 1.3% following the news. However, the stock has gained 5.9% in the past year, underperforming the
industry’s increase of 6.5%.
Importantly, Pfizer’s regulatory application for another candidate, which has recently received acceptance in the United States is lorlatinib, for the second-line treatment of patients with NSCLC. A response from the FDA is awaited in August 2018.
Non-small cell lung cancer occurs in 85% of patients with a lung cancer condition, the leading cause of cancer deaths worldwide. Notably, EGFR mutations leading to growth in cancer cells occur in 10-35% of NSCLC tumors globally. Moreover, despite a significant progress made in this space, the disease is associated with low survival rates. Hence, approval of the candidate will provide the company with access to a huge patient-population base in need of an additional treatment to apprehend the disease.
We remind investors that, Merck’s (
MRK Quick Quote MRK - Free Report) anti-PD-1 therapy, Keytruda, is approved in the first-line lung cancer setting. We also note that last month Roche RHHBY has presented data on Tecentriq in novel combinations across a broad range of tumors including lung cancer.
Blockbuster drugs like Bristol-Myers’ Opdivo is approved for treating NSCLC among others.
Pfizer carries a Zacks Rank #2 (Buy). You can
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