Blinatumomab granted Priority Review in acute lymphoblastic leukemia

FDA granted priority review to the investigational bispecific T-cell engager antibody construct blinatumomab for the treatment of adults with Philadelphia-negative relapsed/refractory B-precursor acute lymphoblastic leukemia.\

Amgen, the drug’s sponsor, also submitted a marketing authorization application to the European Medicines Agency. The submissions include data from a phase II trial of adult patients with Ph- relapsed/refractory B-precursor ALL treated with blinatumomab, which met its primary endpoint.

Blinatumomab, the first of Amgen’s investigational BiTE antibody constructs, has received orphan drug designation from the EMA and FDA, and breakthrough therapy and priority review designation from the FDA for the treatment of ALL.

Blinatumomab is designed to direct T cells against target cells expressing CD19, a protein found on the surface of B-cell derived leukemias and lymphomas. Blinatumomab is also being investigated in pediatric relapsed/refractory ALL, relapsed/refractory Philadelphia positive B-precursor ALL, minimal residual disease positive B-precursor ALL, relapsed/refractory non-Hodgkin’s lymphoma, including relapsed/refractory diffuse large B-cell lymphoma.

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Blinatumomab granted Priority Review in acute lymphoblastic leukemia

YOU MAY BE INTERESTED IN

Letai takes a swipe at “ill-informed commentators,” as he lays out his scientific vision for NCI“To my knowledge, 100% of grants that clear my desk get funded”

As Medicaid work requirements loom, CMS guidance offers automatic exemptions for some cancer patientsCaveat: The guidance is optional. Will states opt in?

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The end of “more money, more people, more trials”Cancer centers are being asked to grow their portfolios on flat budgets. Headcount is the wrong answer.

Harold Freeman, a surgeon who championed health equity, dies at 93Freeman, the father of patient navigation, served as president of ACS and chair of the President’s Cancer Panel

Harold Freeman in his own words“When you fight poverty, you‘re fighting a humanitarian battle for all people.”

Never miss an issue!

Login

Letai takes a swipe at “ill-informed commentators,” as he lays out his scientific vision for NCI
“To my knowledge, 100% of grants that clear my desk get funded”

As Medicaid work requirements loom, CMS guidance offers automatic exemptions for some cancer patients
Caveat: The guidance is optional. Will states opt in?

Scientific progress can’t help people if they can’t access care
This is a policy problem. And it is one we can change.

The end of “more money, more people, more trials”
Cancer centers are being asked to grow their portfolios on flat budgets. Headcount is the wrong answer.

Harold Freeman, a surgeon who championed health equity, dies at 93
Freeman, the father of patient navigation, served as president of ACS and chair of the President’s Cancer Panel

Harold Freeman in his own words
“When you fight poverty, you‘re fighting a humanitarian battle for all people.”