Innate Pharma S.A. (NASDAQ: IPHA) shares jumped on Thursday after the firm announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application for Lumoxiti for adult patients with relapsed or refractory hairy cell leukemia.
The EMA filing is based on the final analysis of the pivotal Phase 3 trial of Lumoxiti, presented at the 2019 American Society of Hematology annual meeting.
The data showed that 36% of the relapsed or refractory hairy cell leukemia patients achieved durable complete response. The objective response rate was at 75%. Eighty-one percent of patients with a complete response experienced eradication of minimal residual disease. In addition, there was a 61% probability that patients who achieved a complete response would maintain it after five years.
The EMA filling acceptance follows the U.S. Food and Drug Administration (FDA) approval of Lumoxiti in September 2018. Lumoxiti was previously granted Orphan Drug Designation by the FDA and EMA. AstraZeneca is the current Biologics License Application holder for Lumoxiti in the United States and is also the marketing authorization applicant for the EU filing.
Pierre Dodion, M.D., executive vice president and chief medical officer of Innate Pharma, commented:
If approved by the EMA, Lumoxiti will be the first treatment available in Europe for relapsed or refractory hairy cell leukemia patients in more than twenty years, potentially changing the standard of care for these patients. We are dedicated in addressing the unmet need in this rare form of cancer that can result in serious and life-threatening conditions, and as such, are hopeful we can bring this important medicine to patients in Europe as soon as possible.
Shares of Innate Pharma were last seen up about 27% at $8.15, in a 52-week range of $5.61 to $8.24. The consensus price target is $12.00.
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