Vincristine Sulfate Liposome

In an attempt to get its house of accelerated approvals in order, the FDA is holding its second adcomm of 2021 to review cancer drugs that won accelerated approvals but failed to confirm clinical benefit in subsequent trials or have taken a long time to read those data out. On Dec. 2, the FDA’s Oncologic Drugs Advisory Committee will review two accelerated approvals from Secura Bio’s Farydak (panobinostat), a third-line multiple myeloma drug, and Acrotech Biopharma’s Marqibo, as a third-line drug for adult patients with Philadelphia chromosome negative acute lymphoblastic leukemia. Both drugs have been marketed for more than five years under their accelerated approvals but have recorded negligible sales in their respective indications in recent years. More information on what exactly happened with both drugs’ confirmatory trials will become clearer two days ahead of the meeting, when FDA releases its briefing documents. The committee will be tasked with deciding whether these indications should remain on the market while additional trial(s) are conducted, the agency said in Thursday’s Federal Register . In the case of Farydak, Novartis won the initial accelerated approval in 2015 but said it likely wouldn’t start the confirmatory trial for almost 3 years, and the FDA gave the company until this year to finish both of its requirements. In March 2019, Secura Bio then bought the drug from Novartis, but sales have fallen below $100 million in recent years, and the accelerated approval for Farydak has never converted into a full approval. Vincent Rajkumar, a professor and cancer doctor at the Mayo Clinic, told Endpoints News that he was one of the authors on one of the panobinostat studies, so it’s hard for him to be objective, but he noted: Secura Bio CMO David Cohan told Endpoints via email: “1. FARYDAK, to date, has not had a negative confirmatory trial. 2. Secura Bio does not yet know what question(s) the FDA intends to ask the ODAC regarding FARYDAK.” In the case of Marqibo, Talon Therapeutics initially won accelerated approval for it in 2012 based on limited data from a single Phase II trial. Spectrum Pharmaceuticals then acquired Talon and the drug for about $11 million in 2013. In 2018, Spectrum reported about $5.5 million in Marqibo sales, and then proceeded to sell the drug a year later with six other cancer drugs to Aurobindo Pharma’s subsidiary Arcotech for $160 million upfront. Meanwhile, Talon had initially agreed to submit the results of its confirmatory trial to the FDA more than three years ago, but it remains unknown if that submission occurred. The push to review these two dangling accelerated approvals comes as the FDA earlier this summer held another ODAC meeting to review six other indications, four of which the committee ended up recommending remain on the market. Since then, three indications have been pulled voluntarily by the companies, and one has gone on to nab a full approval . Rick Pazdur’s Oncology Center for Excellence at FDA also initiated a review of the accelerated approval pathway about a year ago, while more recently, HHS’ inspector general said it also will review the pathway, following a quick accelerated OK for Biogen Alzheimer’s drug Aduhelm.