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AstraZeneca's Lumoxiti Gets FDA Nod for Hairy Cell Leukemia

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AstraZeneca Plc (AZN - Free Report) announced that the FDA has approved Lumoxiti (moxetumomab pasudotox) for the treatment of relapsed or refractory hairy cell leukemia (HCL), a rare blood cancer, in patients who have received at least two prior systemic therapies. Lumoxiti is a CD22-directed cytotoxin and the first of this type of treatment approved for patients with HCL.

The approval was based on a phase III study of 80 patients who had received prior treatment for HCL with at least two systemic therapies including a purine nucleoside analog. The primary endpoint of the study was durable complete response. The study demonstrated that 75% of patients receiving Lumoxiti achieved an overall response, while 30% had a durable complete response.

HCL is a rare form of blood cancer. It is observed that many patients with HCL experience a remission with current treatments, and in 30-40% of these patients, it will relapse after five to ten years from their first treatment. Lumoxiti represents promising non-chemotherapeutic agent for HCL, thereby addressing an unmet medical need.

Shares of AstraZeneca have increased 8.4% year to date compared with the industry’s growth of 6.6%.



AstraZeneca boasts a strong late-stage oncology pipeline. Other than moxetumomab pasudotox, its oncology portfolio includes selumetinib (neurofibromatosis type 1) and savolitinib (kidney cancer). An interesting candidate in the company’s immuno-oncology pipeline is Imfinzi (durvalumab), which is being evaluated for multiple cancers, either alone or in combination with other regimens. Imfinzi is presently marketed in the United States for second-line advanced bladder and early-stage lung cancer (NSCLC).

Lynparza, presently marketed in partnership with Merck (MRK - Free Report) for advanced ovarian and breast cancer, is also being evaluated in different studies for a range of tumor types including prostate and pancreatic cancers, as well as earlier-line settings for ovarian cancer. Tagrisso is also being evaluated in earlier-line settings for lung cancer.

Zacks Rank & Stocks to Consider

AstraZeneca is currently a Zacks Rank #3 (Hold) stock.

Some better-ranked stocks in the same space are Roche Holding AG (RHHBY - Free Report) , and Eli Lilly and Company (LLY - Free Report) . Both of them carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Lilly’s earnings per share estimates have increased from $5.16 to $5.47 for 2018 and from $5.53 to $5.73 for 2019 over the past 60 days. The company delivered a positive earnings surprise in all of the trailing four quarters with an average beat of 10.15%. The stock has rallied 22.7% in the past three months.

Roche’s earnings per share estimates have increased from $2.10 to $2.24 for 2018 and from $2.15 to $2.28 for 2019 over the past 60 days. The stock has rallied 16.2% in the past three months.

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