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FDA’s ongoing review of accelerated cancer approvals targets 2 drugs from Secura and Aurobindo

September 24, 2021


The FDA initially targeted immunotherapies in its industry-wide review of accelerated drug approvals in oncology that failed to deliver in confirmatory trials. But the agency isn’t stopping there.

The FDA is gathering an oncologic drugs advisory committee meeting on Dec. 2 to review whether two drugs should keep their conditional approvals, the agency said Friday. The products are Secura Bio’s Farydak for previously treated multiple myeloma, and Aurobindo Pharma’s Marqibo indication for Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL) following two or more lines of treatments.

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