Talon Therapeutics Inc (fka TLON)

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FDA’s accelerated approval program: Is change on the way?

"The FDA has also been revisiting cancer therapy approvals made through the program. In April 2021, the agency convened the Oncologic Drugs Advisory Committee (ODAC) to review six so-called dangling accelerated approvals in which the confirmatory trials had failed but the drug remained on the market. Of the six checkpoint inhibitor indications reviewed, ODAC recommended that four be maintained (RELATED: ODAC recommends pulling 2 of 6 accelerated approvals, Regulatory Focus 30 April 2021).

The committee is scheduled to meet again on 2 December to review dangling accelerated approvals for Farydak (panobinostat) for multiple myeloma and Marqibo (vincristine sulfate liposome injection) for adults with Philadelphia chromosome negative acute lymphoblastic leukemia. Novartis received accelerated approval for the multiple myeloma indication in 2014, and Talon Therapeutics’ Marquibo got its accelerated approval nod in 2012."

https://www.raps.org/news-and-articles/news-articles/2021/10/fdas-ccelerated-approval-program-is-change-on-the