The FDA’s Accelerated Approval Program allows for the earlier approval of drugs to fill an unmet clinical need, according to the agency’s website.
The agency approved the drug, Lartruvo, for combined use with the chemotherapy agent doxorubicin in soft tissue sarcoma patients who cannot be cured with radiation or surgery, according to the report.
Lartruvo earned orphan drug status and breakthrough therapy status — designations intended to expedite the development and review of promising new drugs — from the FDA prior to winning accelerated approval.
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