FDA flags possible dasatinib–methotrexate interaction; PAC backs further review
Summary
CDER told the PAC it identified a potential drug–drug interaction between dasatinib and methotrexate and launched a NIST review; the committee voted to support the agency’s further evaluation and surveillance of the product under review.
CDER reviewers reported a potential newly identified pediatric safety signal involving dasatinib and methotrexate and said an internal NIST (newly identified safety signal) assessment is underway.
"We found this potential drug drug interaction concern with dasatinib and methotrexate," the CDER presenter said, adding the center had launched the NIST process to gather a multidisciplinary team to evaluate the observation and determine appropriate actions after a thorough review of available data.
The PAC voted in support of additional FDA investigation for the product tied to the identified signal: the meeting record shows that for the product discussed under that question the vote was 13 yes, 0 no, 0 abstain. FDA said it will continue with surveillance activities and report back with results of the NIST evaluation when completed.
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