The Committee for Medicinal Products for Human Use of the EMA recommended that both Mylotarg (gemtuzumab ozogamicin) and Bosulif (bosutinib) be reviewed separately by the European Commission.
On Friday, Pfizer received positive opinions for two of its hematology medicines.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended that both Mylotarg (gemtuzumab ozogamicin) and Bosulif (bosutinib) be reviewed separately by the European Commission (EC).
The former is currently in development and intended to be used in combination with daunorubicin and cytarabine in patients age 15 years and older with previously untreated, de novo, CD33-positive acute myeloid leukemia (AML), except acute promyelocytic leukemia (APL). Bosutinib’s positive opinion was granted as it pertains to the drug’s use to treat adults with newly diagnosed chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML).
The U.S. Food and Drug Administration has previously approved both drugs for these indications. Gemtuzumab ozogamicin was originally approved for use in 2000 as a stand-alone treatment for older patients with CD33-positive AML who had experienced relapse, but was voluntarily withdrawn from the market after later tests questioned its safety and clinical benefit. In September, the FDA approved the targeted therapy for the treatment of adults with newly diagnosed AML. In December, the U.S. indication for which bosutinib is approved was expanded to include patients with newly-diagnosed Ph+ CML.
Gemtuzumab ozogamicin’s marketing authorization application (MAA) was based on data from investigator-led, Phase 3, randomized, open-label ALFA-0701 study, which enrolled previously untreated, de novo patients.
Bosutinib has conditional marketing authorization in Europe related to the initial marketing authorization, and the Type II Variation application for the drug in this adult patient population was based on results from the randomized, multicenter, multinational, open-labal Phase 3, head-to-head BFORE (Bosutinib trial in First line ChrOnic myelogenous leukemia tREatment) study.
“There is an urgent need to improve outcomes for leukemia patients in Europe,” said Mace Rothenberg, M.D., Pfizer Global Product Development’s Chief Development Officer of Oncology in a press release. “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.”
Common side effects of gemtuzumab ozogamicin include: fever, nausea, infection, vomiting, and bleeding, among others. In the U.S., the drug comes with a boxed warning including the mention of severe or fatal liver damage, including blockage of veins in the liver.
The adverse events (AEs) seen in the BFORE trial were consistent with the known safety profile of bosutinib, and the most common adverse reactions in patients treated with it included: diarrhea, nausea, thrombocytopenia, rash, increased alanine aminotransferase, abdominal pain, and increased aspartate aminotransferase.
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