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Lymphoma and Pets
ODAC endorses Talon's Marqibo for ALL
The FDA's Oncologic Drugs Advisory Committee (ODAC) has given its endorsement to vincristine sulfate liposomal injection, marketed as Marqibo, for approval.
The endorsement didn't come easily, with the panel voting to endorse it 7-4 along with two committee members abstaining from the vote.
Talon pharmaceuticals is seeking to have Marqibo approved for the treatment of patients with Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or who have failed at least two prior treatments with other anti-leukemia drugs.
This is a very rare type of cancer with a very poor prognosis.
The vote on Marqibo surprises no one, since the data was not very strong, but panelists likely felt swayed by the fact that there are no other options for this patient population.
The FDA can still reject the drug, but it typically takes the ODAC's recommendations.