Michael Weiss, TG Therapeutics CEO

FDA rais­es con­cerns over TG Ther­a­peu­tic­s' sur­vival da­ta, plans to con­vene ODAC

TG Ther­a­peu­tics took a hit Tues­day morn­ing af­ter an­nounc­ing the FDA will con­vene an ad­comm ahead of the biotech’s up­com­ing PDU­FA date for a blood can­cer com­bo ther­a­py, throw­ing a po­ten­tial de­ci­sion in­to lim­bo.

Though the ex­act date has not been de­ter­mined, reg­u­la­tors are look­ing to hold a meet­ing of the On­co­log­ic Drugs Ad­vi­so­ry Com­mit­tee some­time in March or April, TG said in a re­lease. Giv­en that tim­ing, the biotech says it’s now un­like­ly the FDA will reach an ap­proval de­ci­sion by the March 25 dead­line.

“We look for­ward to the ODAC meet­ing as we be­lieve it will pro­vide us an op­por­tu­ni­ty to high­light the im­por­tant role U2 can play in the treat­ment of CLL,” CEO Michael Weiss said in a state­ment.

In the wake of the news, TG shares $TGTX cratered by near­ly 45% as the mar­ket opened Tues­day morn­ing.

The pro­gram in ques­tion is a com­bi­na­tion of ubli­tux­imab and um­bral­is­ib, which the biotech has re­ferred to as U2 (no re­la­tion to the Bono-led band). TG has been re­search­ing the ther­a­py to treat adults with chron­ic lym­pho­cyt­ic leukemia and small lym­pho­cyt­ic lym­phoma.

Ac­cord­ing to TG, the FDA is call­ing ODAC to­geth­er over ques­tions about the pro­gram’s over­all sur­vival ben­e­fits, some­thing that was not an­a­lyzed in the in­ter­im analy­sis, Weiss said in an in­vestor call Tues­day. OS had been in­clud­ed as a sec­ondary mea­sure, but was in­stead pow­ered to mea­sure pro­gres­sion-free sur­vival.

TG pro­vid­ed sur­vival in­fo to reg­u­la­tors as part of the BLA and sN­DA re­view, but Weiss not­ed it was not in­clud­ed orig­i­nal­ly. The CEO said TG and the FDA had agreed be­fore the study that the sur­vival da­ta would have been too im­ma­ture and “too small to be in­for­ma­tive” had the com­pa­ny at­tempt­ed to mea­sure OS.

The da­ta TG even­tu­al­ly pro­vid­ed in­clud­ed an ear­ly analy­sis show­ing no sta­tis­ti­cal­ly sig­nif­i­cant dif­fer­ence in sur­vival be­tween the treat­ment arms, Weiss said. He high­light­ed that the haz­ard ra­tio of 1.23 ap­peared to show an im­bal­ance in fa­vor of the con­trol arm, though when ex­clud­ing deaths re­lat­ed to Covid-19, the HR fell to 1.04 — again with no sta­tis­ti­cal­ly sig­nif­i­cant dif­fer­ence.

Weiss al­so at­tempt­ed to ease in­vestor con­cerns over the hear­ing, ex­plain­ing that there is “prece­dent” for the ap­proval of drugs that seem­ing­ly fa­vor sur­vival con­trol arms. He point­ed to Ab­b­Vie and Roche’s Ven­clex­ta as one ex­am­ple, not­ing the drug had “no ODAC and OS was clear­ly in fa­vor of the GC arm at the time of ap­proval,” in re­sponse to an an­a­lyst ques­tion.

Time will tell whether ODAC heeds the FDA’s con­cerns, but the news marks an­oth­er bump in TG’s quest to get the U2 com­bo past the fin­ish line — tim­ing that re­mains up in the air. In Sep­tem­ber 2018, the biotech was sup­posed to read out ORR da­ta for the ther­a­py but the safe­ty mon­i­tor­ing board said at the time the da­ta weren’t ma­ture enough.

TG brought in­vestors back to the ta­ble in May 2020, how­ev­er, read­ing out pos­i­tive topline Phase III re­sults that showed it hit the PFS thresh­old in an in­ter­im analy­sis. In the full dataset re­vealed at ASH in De­cem­ber 2020, TG showed off stel­lar p-val­ues in PFS and ORR (p<0.0001 and p<0.001, re­spec­tive­ly) while say­ing um­bral­is­ib as a monother­a­py al­so hit a 49.3% over­all re­sponse rate.

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.

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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.

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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.

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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.

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UP­DAT­ED: 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.

Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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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.

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.