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Pfizer's (PFE) Lung Cancer Drug Vizimpro Gets FDA Approval

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Pfizer Inc. (PFE - Free Report) announced that the FDA has approved Vizimpro (dacomitinib) for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in patients with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations. Vizimpro was reviewed and approved under the FDA’s Priority Review program.

The approval was supported by positive data from a global head-to-head phase III ARCHER 1050 study. The study evaluated dacomitinib (n=227) versus AstraZeneca’s (AZN - Free Report) lung cancer drug, Iressa (gefitinib) in patients with NSCLC with no prior therapy for metastatic disease or recurrent disease and who have been disease free for minimum of 12 months after completion of systemic therapy. 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%.

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 has low survival rates.

Shares of Pfizer have gained 21.2% year to date, outperforming the industry’s growth of 7.0%.

Pfizer now has two medicines that can tackle three different forms of mutation-driven lung cancer — Xalkori for patients with ALK-positive or ROS1-positive NSCLC and Vizimpro.

The company has three other candidates in its oncology pipeline. These include glasdegib, which is being developed for previously untreated acute myeloid leukemia (AML) in combination studies and has an action date in December 2018; lorlatinib, which is being developed for the second line treatment of non-small-cell lung cancer; and talazoparib, which is being developed to treat advanced breast cancer, with an action date of December 2018.

We remind investors that Merck’s (MRK - Free Report) anti-PD-1 therapy, Keytruda, an immune-oncology drug, is approved in the first-line lung cancer setting. Blockbuster drugs like Bristol-Myers’ (BMY - Free Report) Opdivo, also an immune-oncology drug, is approved for treating NSCLC, among others.


Zacks Rank

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

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