EMA approves marketing authorization application for Lumoxiti®
Category: #health  By Mateen Dalal  Date: 2020-01-03
  • share
  • Twitter
  • Facebook
  • LinkedIn

EMA approves marketing authorization application for Lumoxiti®

Innate Pharma SA, a commercial-stage oncology-focused biotech firm, has successfully attain Marketing Authorization Application (MMA) approval for Lumoxiti from the European Medicines Agency (EMA). For the record, Lumoxiti is a first-in-class drug directed for adult patients who are suffering from refractory or relapsed hairy cell leukemia (HCL) and have received a minimum two preceding systemic therapies, including treatment with a purine nucleoside analog. 

Speaking on the approval, Pierre Dodion, MD, Executive VP & CMO, Innate Pharma, said that the drug, following its authorization by the EMA, would become first treatment available in Europe for relapsed or refractory HCL patients in over twenty years, potentially transforming the standard of care for these patients.

Dodion assured that their firm is dedicated towards addressing the unmet need for treating this rare type of cancer that could result in fatal conditions and would bring this drug to patent in Europe as soon as possible.

As per reports, the EMA filing was based on the final study of the Phase III trial of Lumoxiti, demonstrated at ASH 2019. According to the data, around 36 percent (29/80) of the relapsed or refractory HCL patients attained durable complete response (specified as a CR) with a hematological remission retained for at least 180 days.

The ORR (objective response rate) was at 75%, whereas 81% of patients with CR underwent elimination of minimal residual disease as reflected by MRD-negative status. Additionally, there was a 61% possibility that patients who attained a CR would retain it after five years.

Reportedly, the EMA filing acceptance for Lumoxiti follows the U.S. FDA (Food and Drug Administration) approval in Sept. 2018.

About Innate Pharma S.A.

It is an oncology-focused biotech organization dedicated to improving clinical and treatment results for patients through therapeutic antibodies that utilize the immune system to fight against cancer.
 

Souce Creidit – https://www.innate-pharma.com/en/news-events/press-releases/european-medicines-agency-accepts-regulatory-submission-lumoxiti-relapsed-or-refractory-hairy-cell-leukemia

  • share
  • Twitter
  • Facebook
  • LinkedIn


About Author

Mateen Dalal    

Mateen Dalal

A qualified electronics and telecommunication engineer, Mateen Dalal embarked on his professional journey working as a quality and test engineer. Harnessing his passion for content creation however, Mateen pens down industry-rich articles for ReportsGO.com and a few o...

Read More

More News By Mateen Dalal

Scientists devise method to decrease coronavirus count in plasma, blood
Scientists devise method to decrease coronavirus count in plasma, blood
By Mateen Dalal

Ever since COVID-19 has ravaged the globe, claiming more than 3 lakh lives, various research organizations and scientists the world over, have been striving to introduce a vaccine or a medication or a potential method which could not only reduce the ...

Netsmart introduces unique mobile screening solution for COVID-19
Netsmart introduces unique mobile screening solution for COVID-19
By Mateen Dalal

In the face of the ongoing pandemic spread worldwide, that has disrupted businesses and turned normal lives upside down, companies have been striving to bring about innovative solutions that can ensure people to remain adequately and correctly inform...

First suspected cases of MIS-C under examination in South Korea
First suspected cases of MIS-C under examination in South Korea
By Mateen Dalal

Health authorities in South Korea have lately announced the ongoing medical examination of two children cited as suspected cases of a life-threatening syndrome associated with coronavirus. The two children are apparently the first suspected cases of ...