logo
Plus   Neg
Share
Email

Pfizer Gets Positive CHMP Opinion For Mylotarg And Bosulif - Quick Facts

Pfizer Inc. (PFE) said that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency (EMA) has adopted positive opinions recommending that two of the company's hematology medicines be granted marketing authorizations in the European Union or EU.

Mylotarg or gemtuzumab ozogamicin, in combination with daunorubicin and cytarabine, has been granted a positive opinion by the CHMP for the treatment of patients aged 15 years and above with previously untreated, de novo, CD33-positive acute myeloid leukemia or AML, except acute promyelocytic leukemia or APL.

Bosulif or bosutinib has been granted a positive opinion for the treatment of adults with newly diagnosed chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML).

The CHMP's opinions for both medicines will now be reviewed separately by the European Commission or EC.

Mace Rothenberg, chief development officer, Oncology, Pfizer Global Product Development, said, "If approved, the addition of MYLOTARG to standard chemotherapy will provide an important new treatment option for patients with acute myeloid leukemia who would typically be treated with chemotherapy alone. Additionally, the potential expansion of the approved use of BOSULIF to include first-line therapy expands the treatment options for adult patients with newly diagnosed chronic myelogenous leukemia."

According to Pfizer, Mylotarg's Marketing Authorization Application or MAA was based on data from an investigator-led, Phase 3, randomized, open-label study or ALFA-0701 in previously untreated, de novo patients.

Pfizer noted that Bosulif currently has conditional marketing authorization in Europe related to the initial marketing authorization.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Tech giant Apple Inc. (AAPL) is reportedly planning to begin assembling a new low-cost iPhone 9 in February. According to Bloomberg, the Cupertino, California-based company is expected to officially unveil the new phone as early as March. The assembly work for the new handset will be split among Taiwan-based... A Louisville, Kentucky-based franchise of Wendy's and Fazoli's restaurants, was ordered by the federal government to pay a civil penalty of $157,114 for violating child labor laws. The U.S. Department of Labor's Wage and Hour Division or WHD said its investigation found that Manna Inc. violated child labor requirements of the Fair Labor Standards Act at 99 Wendy's and Fazoli's restaurants. Tesla's market capitalization briefly crept up the $100 billion mark in extended trading on Tuesday, making it the first publicly-listed automaker in the U.S. to achieve the feat. Tesla's stock gained 7.2 percent to close Tuesday's regular trading session at $547.20, and rose to $555 in after-hours trading, pushing the luxury electric car maker's market valuation to more than $100 billion.
Follow RTT
>