Dan O'Day, Gilead CEO (Jim Watson/AFP via Getty Images)

Fail­ing to con­firm clin­i­cal ben­e­fit, Gilead pulls 2 ac­cel­er­at­ed ap­proval in­di­ca­tions for can­cer drug

Gilead re­cent­ly de­cid­ed to pull two in­di­ca­tions for its can­cer drug Zy­delig — in re­lapsed fol­lic­u­lar B-cell non-Hodgkin lym­phoma (FL) and re­lapsed small lym­pho­cyt­ic leukemia (SLL) — af­ter fail­ing to com­plete the con­fir­ma­to­ry tri­als re­quired as part of the ac­cel­er­at­ed ap­provals from 2014.

“As the treat­ment land­scape for FL and SLL has evolved, en­roll­ment in­to the con­fir­ma­to­ry study has been an on­go­ing chal­lenge,” Gilead said in a state­ment, not­ing it for­mal­ly no­ti­fied the FDA of its de­ci­sion to vol­un­tar­i­ly with­draw these in­di­ca­tions.

Zy­delig was al­so ap­proved in 2014 to treat re­lapsed chron­ic lym­pho­cyt­ic leukemia in the US and will re­main on the mar­ket for that in­di­ca­tion. Lym­phoma doc­tor John Leonard wrote on Twit­ter the drug will like­ly still re­main avail­able off-la­bel for those two us­es that Gilead is pulling.

But with just $150 mil­lion in world­wide sales in 2019 and 2020 com­bined, Zy­delig has yet to near block­buster sta­tus, and the drug’s list price has risen con­sid­er­ably over the years, from $7,200 per month in 2014, when it first won ap­proval, to al­most $11,000 per month in 2019.

Ad­di­tion­al­ly, Zy­delig has mar­ket­ing au­tho­riza­tion to treat CLL and FL in the EU, UK, Cana­da, Aus­tralia, New Zealand and Switzer­land. None of these ap­provals are af­fect­ed by these with­drawals, Gilead said.

Zy­delig is a first-in-class in­hibitor of PI3K delta, a pro­tein that is over­ex­pressed in many B-cell ma­lig­nan­cies and plays a role in the vi­a­bil­i­ty, pro­lif­er­a­tion and mi­gra­tion of these can­cer cells.

The de­ci­sion by Gilead to pull these two in­di­ca­tions comes as the FDA has sought to clean house around so-called “dan­gling” ac­cel­er­at­ed ap­provals, mean­ing they have yet to com­plete or failed their con­fir­ma­to­ry tri­als.

Fol­low­ing an ODAC meet­ing last sum­mer to re­view six dan­gling in­di­ca­tions, three in­di­ca­tions have since been pulled vol­un­tar­i­ly by the com­pa­nies, and one has gone on to a full ap­proval. Oth­ers, like Se­cu­ra Bio, have al­so re­cent­ly pulled a dan­gling ac­cel­er­at­ed ap­proval.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

(Credit: Shutterstock)

Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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Robert Califf (Michael Brochstein/Sipa USA via AP Images)

House Re­pub­li­cans at­tack Chi­na-on­ly da­ta in FDA sub­mis­sions, seek new in­ves­ti­ga­tion in­to re­search in­spec­tions

Three Republican representatives are calling on the FDA to take a closer look at the applications including only clinical data from China.

The letter to FDA commissioner Rob Califf late last week comes as the agency recently rejected Eli Lilly’s anti-PD-1 antibody, which attempted to bring China-only data but ran into a bruising adcomm that may crush the hopes of any other companies looking to bring cheaper follow-ons based only on Chinese data.

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Co­pay coupons gone wrong, again: Pfiz­er pays al­most $300K to set­tle com­plaints in four states

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

Delaware court rules against Gilead and Astel­las in years-long patent case

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.

Taye Diggs (courtesy Idorsia)

Idor­sia inks an­oth­er celebri­ty en­dors­er deal with ac­tor and dad Taye Dig­gs as Qu­viviq in­som­nia am­bas­sador

Idorsia’s latest Quviviq insomnia campaign details the relatable dad story of a well-known celebrity — actor and Broadway star Taye Diggs.

Diggs stopped sleeping well after the birth of his son, now more than 10 years ago. Switching mom-and-dad nightly shifts to take care of a baby interrupted his sleep patterns and led to insomnia.

“When you’re lucky enough to be living out your dream and doing what you want, but because of something as simple as a lack of sleep, you’re unable to do that, it felt absolutely — it was treacherous,” he says in an interview-style video on the Quviviq website.

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Belén Garijo, Merck KGaA CEO (Kevin Wolf/AP Images for EMD Serono)

Mer­ck KGaA pumps €440M in­to ex­pand­ing and con­struct­ing Irish man­u­fac­tur­ing fa­cil­i­ties

The area of Ireland famous for Blarney Castle and its cliffsides along the Atlantic Ocean is seeing Merck KGaA expand its commitment there.

The German drug manufacturer is expanding its membrane and filtration manufacturing capabilities in Ireland. The company will invest approximately €440 million ($470 million) to increase membrane manufacturing capacity in Carrigtwohill, Ireland, and build a new manufacturing facility at Blarney Business Park, in County Cork, Ireland.

Rep. Katie Porter (D-CA) (Michael Brochstein/Sipa USA/Sipa via AP Images)

House Dems to Sen­ate lead­er­ship: Quick­ly move a rec­on­cil­i­a­tion bill with drug price ne­go­ti­a­tion re­forms

Twenty House Democrats, including Reps. Katie Porter of California and Susan Wild of Pennsylvania, are calling on Senate leaders to move quickly with a reconciliation bill (meaning they only need a simple majority for passage) with prescription drug pricing reforms, and to include adding new authority for Medicare to negotiate drug prices.

They also called on the Senate to specifically follow suit with the House passage of a $35 per month insulin cap (as Senate Majority Leader Chuck Schumer’s deadline for a vote on that provision has come and gone), and to cap Medicare Part D costs at $2,000 per year for seniors.