UP­DAT­ED: 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.

Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,600+ biopharma pros reading Endpoints daily — and it's free.

Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,600+ biopharma pros reading Endpoints daily — and it's free.

Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,600+ biopharma pros reading Endpoints daily — and it's free.

Alexander Lefterov/Endpoints News

A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

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.

FDA slams Eli Lil­ly's 'mis­lead­ing' In­sta­gram ad for its type 2 di­a­betes in­jec­tion

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.

US re­stricts use of two mon­o­clon­al an­ti­bod­ies that don't work against Omi­cron

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.

Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

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.

Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,600+ biopharma pros reading Endpoints daily — and it's free.