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.

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

In a first for 2022, the FDA’s Office of Prescription Drug Promotion has issued an untitled letter, which was recently sent to Eli Lilly over what the agency calls a “misleading” and “particularly concerning” Instagram ad the company posted for its type 2 diabetes drug Trulicity.

The questionable Instagram post, which has since been deleted by Lilly, failed to adequately communicate the indication and limitations of use associated with Trulicity, FDA says.

Two monoclonal antibody combos from Eli Lilly and Regeneron are no longer authorized in the US, and shipments to states have ceased because HHS said they are “highly unlikely” to work against the sweeping new variant Omicron.

The move by the FDA comes as states like Florida have become insistent that the mAbs need to be independently evaluated, although the federal Department of Health and Human Services, which has shipped hundreds of thousands of these two mAbs to states in recent weeks, did not ship any this week.

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.