FDA cancels ODAC meeting this week as Secura Bio pulls accelerated approval
The FDA’s Oncologic Drugs Advisory Committee has decided to cancel a planned meeting on Thursday to discuss two cancer drugs that previously won accelerated approvals but failed to confirm clinical benefit in required follow-up trials or have taken a long time to finish those trials.
Secura Bio said late Tuesday afternoon that it’s decided to pull its third-line multiple myeloma drug Farydak, first approved under the accelerated pathway in 2015.
The company, which bought the drug from Novartis in 2019, explained its decision by saying, “it was not feasible for the company to complete the required post-approval clinical studies as designed as part of the accelerated approval process. Because those studies were required to verify and describe the clinical benefit of the drug product, the clinical benefit of Farydak has not been confirmed under the specific constraints of the accelerated approval process.”
ODAC was also set to discuss Acrotech Biopharma’s Marqibo, a third-line drug for adult patients with Philadelphia chromosome negative acute lymphoblastic leukemia. Neither Acrotech nor its parent company Aurobindo has responded to a request for comment.
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 three years, and the FDA gave the company until this year to finish both of its requirements.
In the case of Marqibo, Talon Therapeutics initially won the accelerated approval in 2012 based on 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 Acrotech 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 followed another ODAC meeting last summer 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.
The FDA said in a statement that the meeting “is no longer needed” but did not offer further detail on why exactly it was canceled, telling Endpoints News to contact the companies.
Editor’s note: This article has been updated with new information from Secura Bio.