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Pfizer's (PFE) Xalkori Positive in Another Phase III Study

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Pfizer Inc.PFE announced that its cancer treatment, Xalkori, achieved the primary endpoint in a phase III study (PROFILE 1029) in previously untreated East Asian patients with ALK-positive advanced non-small cell lung cancer (NSCLC).

Results showed that Xalkori prolonged progression free survival compared to a standard chemotherapy doublet.

Pfizer said that this is the second positive late-stage study on Xalkori in the first-line setting and the third positive phase III study in ALK-positive NSCLC. Xalkori is currently approved for the treatment of ALK-positive metastatic NSCLC. The product generated sales of $353 million in the first nine months of 2015.

Meanwhile, Pfizer along with its partner Merck KGaA MKGAF announced that they have received Breakthrough Therapy designation for their experimental cancer treatment, avelumab. The FDA granted the designation for the treatment of patients with metastatic Merkel cell carcinoma (MCC) whose disease has progressed after at least one previous chemotherapy regimen.

Avelumab, an anti-PD-L1 IgG1 monoclonal antibody, is currently in a global multicenter, single-arm, open-label phase II study -- JAVELIN Merkel 200 -- which is evaluating the candidate's safety and efficacy in patients with metastatic MCC whose disease has progressed after at least one prior chemotherapy regimen. Results from this study will be presented at scientific congresses in 2016.

Breakthrough Therapy designation helps fasten the development and review of drugs which are being evaluated for the treatment of serious conditions and where preliminary clinical evidence indicates that the drug may be substantially better than existing treatments on clinically significant endpoint(s).

According to information provided in the company's press release, about 1,500 new cases of MCC, a rare and aggressive type of skin cancer, are diagnosed every year in the U.S. Currently, no treatments are approved specifically for metastatic MCC.

We note that avelumab also has Fast Track and Orphan Drug status in the U.S. for the treatment of metastatic MCC.

Pfizer is a Zacks Rank #3 (Hold) stock. The company has been in the news related to its interest in acquiring Ireland-based Allergan plc AGN .

Eli Lilly and Company LLY is a better-ranked stock in the healthcare sector with a Zacks Rank #2 (Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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