As it takes Lartru­vo off the shelves, Lil­ly is set­ting up pro­gram to pro­vide drug ac­cess to cur­rent pa­tients

When Lil­ly’s ap­proved soft tis­sue sar­co­ma drug Lartru­vo un­ex­pect­ed­ly failed to help pa­tients live longer in a late-stage study in Jan­u­ary, US and EU reg­u­la­tors dis­cour­aged new pa­tients from start­ing treat­ment with the med­i­cine, and the drug­mak­er sus­pend­ed its pro­mo­tion of the ther­a­py.

Lartru­vo was cleared for use by the FDA un­der the ac­cel­er­at­ed ap­proval path­way — an in­creas­ing­ly pop­u­lar mech­a­nism used by the agency to has­ten the pace of ap­provals —  in 2016, and the con­fir­ma­to­ry Phase III tri­al was in­tend­ed to con­firm the drug’s ben­e­fit. Since the tri­al was un­suc­cess­ful, Lil­ly was ex­pect­ed to re­scind the drug from the mar­ket.  On Thurs­day, the com­pa­ny $LLY said it was work­ing on set­ting up a pro­gram so cur­rent pa­tients can still ac­cess Lartru­vo with “lim­it­ed in­ter­rup­tion” af­ter it is of­fi­cial­ly with­drawn.

Lil­ly said it was un­able to spec­u­late when the drug will be of­fi­cial­ly with­drawn, a spokesper­son told End­points News.

Lartru­vo, which gen­er­at­ed near­ly $305 mil­lion in sales last year, was ap­proved in com­bi­na­tion with the chemother­a­py dox­oru­bicin as a front­line treat­ment for a sub­set of pa­tients with soft tis­sue sar­co­ma (STS), a dis­ease that had seen no new ap­provals in decades.

In 2019, an es­ti­mat­ed 12,750 new STS cas­es will be di­ag­nosed, and more than 5,000 Amer­i­cans will suc­cumb to the dis­ease, ac­cord­ing to the Amer­i­can Can­cer So­ci­ety.

“(P)atients who are cur­rent­ly re­ceiv­ing Lartru­vo may, in con­sul­ta­tion with their physi­cian, con­tin­ue their course of ther­a­py if they have been in­formed of the risks of Lartru­vo and the re­sults of the (failed) AN­NOUNCE study and wish to con­tin­ue, sub­ject to lo­cal laws and reg­u­la­tions,” Lil­ly said in a state­ment.

Physi­cians will need to work with the com­pa­ny to set up con­tracts to en­roll their fa­cil­i­ties, and pa­tients will need to pro­vide writ­ten con­sent to en­roll in the pro­gram — if these steps are tak­en then cur­rent pa­tients should be able to ac­cess Lartru­vo free of charge, the spokesper­son said.

The US list price for the drug was $2,456 per 500 mg vial and $933.28 per 190 mg vial, and the av­er­age price at six month du­ra­tion of ex­po­sure would be $106,099.20, the spokesper­son not­ed, adding that a pa­tient’s out-of-pock­et cost would de­pend on var­i­ous fac­tors in­clud­ing in­sur­ance cov­er­age and med­ical as­sis­tance pro­grams.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA have vowed not to let politics get in the way of science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped health agencies under his purview — including the FDA — of their rulemaking ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Donald Trump and White House chief of staff Mark Meadows, before boarding Marine One (Getty Images)

Pric­ing deal col­laps­es over Big Phar­ma's re­fusal to is­sue $100 'cash card­s' be­fore the elec­tion — re­port

Late in August, as negotiations on a pricing deal with President Trump reached a boiling point, PhRMA president Stephen Ubl sent an email update to the 34 biopharma chiefs that sit on his board. He wrote that if the industry did not agree to pay for a $100 “cash card” sent to seniors before November, White House chief of staff Mark Meadows was going to tell the news media Big Pharma was refusing to “share the savings” with the elderly — and that all of the blame for failed drug pricing negotiations would lie squarely on the industry.

#ES­MO20: As­traZeneca aims to spur PRO­found shift in prostate can­cer treat­ment with Lyn­parza OS da­ta

AstraZeneca has unveiled the final, mature overall survival data that cemented Lynparza’s first approval in prostate cancer approval — touting its lead against rivals with the only PARP inhibitor to have demonstrated such benefit.

But getting the Merck-partnered drug to the right patients remains a challenge, something the companies are hoping to change with the new data cut.

The OS numbers on the subgroup with BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer are similar to the first look on offer when the FDA expanded the label in May: Lynparza reduced the risk of death by 31% versus Xtandi and Zytiga. Patients on Lynparza lived a median of 19.1 months, compared to 14.7 months for the anti-androgen therapies (p = 0.0175).

Eli Lilly CSO Dan Skovronsky (file photo)

#ES­MO20: Eli Lil­ly shows off the da­ta for its Verzenio suc­cess. Was it worth $18 bil­lion?

The press release alone, devoid of any number except for the size of the trial, added nearly $20 billion to Eli Lilly’s market cap back in June. Now investors and oncologists will get to see if the data live up to the hype.

On Sunday at ESMO, Eli Lilly announced the full results for its Phase III MonarchE trial of Verzenio, showing that across over 5,000 women who had had HR+, HER2- breast cancer, the drug reduced the odds of recurrence by 25%. That meant 7.8% of the patients on the drug arm saw their cancers return within 2 years, compared with 11.3% on the placebo arm.

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Greg Friberg (File photo)

#ES­MO20: Am­gen team nails down sol­id ear­ly ev­i­dence of AMG 510’s po­ten­tial for NSCLC, un­lock­ing the door to a wave of KRAS pro­grams

The first time I sat down with Amgen’s Greg Friberg to talk about the pharma giant’s KRAS G12C program for sotorasib (AMG 510) at ASCO a little more than a year ago, there was high excitement about the first glimpse of efficacy from their Phase I study, with 5 of 10 evaluable non-small cell lung cancer patients demonstrating a response to the drug.

After decades of failure targeting KRAS, sotorasib offered the first positive look at a new approach that promised to open a door to a whole new approach by targeting a particular mutation to a big target that had remained “undruggable” for decades.

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#ES­MO20: Out to beat Tagris­so, J&J touts 100% ORR for EGFR bis­pe­cif­ic/TKI com­bo — fu­el­ing a quick leap to PhI­II

J&J’s one-two punch on EGFR-mutant non-small cell lung cancer has turned up some promising — although decidedly early — results, fueling the idea that there’s yet room to one up on third-generation tyrosine kinase inhibitors.

Twenty out of 20 advanced NSCLC patients had a response after taking a combination of an in-house TKI dubbed lazertinib and amivantamab, a bispecific antibody targeting both EGFR and cMET engineered on partner Genmab’s platform, J&J reported at ESMO. All were treatment-naïve, and none has seen their cancer progress at a median follow-up of seven months.

#ES­MO20: As­traZeneca bur­nish­es Tagris­so's ad­ju­vant NSCLC pro­file with 'un­prece­dent­ed' re­duc­tion in brain mets. Can they win over skep­tics?

When AstraZeneca trumpeted “momentous” and “transformative” results for Tagrisso earlier this year at ASCO, some practitioners threw cold water on the ADAURA fervor. Sure, the disease-free survival data look good, but overall survival is the endpoint that matters when it comes to choosing adjuvant therapy for non-small cell lung cancer patients, the experts said.

The OS data still aren’t here, but AstraZeneca is back at ESMO to bolster their case with a look at brain metastasis data.

Exelixis CEO Michael Morrissey (file photo)

#ES­MO20: Look out Mer­ck. Bris­tol My­ers and Ex­elix­is stake out their com­bo’s claim to best-in-class sta­tus for front­line kid­ney can­cer

Now that the PD-(L)1 checkpoints are deeply entrenched in the oncology market, it’s time to welcome a wave of combination therapies — beyond chemo — looking to extend their benefit to larger numbers of patients. Bristol Myers Squibb ($BMY} and Exelixis {EXEL} are close to the front of that line.

Today at ESMO the collaborators pulled the curtain back on some stellar data for their combination of Opdivo (the PD-1) and Cabometyx (the TKI), marking a significant advance for the blockbuster Bristol Myers franchise while offering a big leg up for the team at Exelixis.

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Dan Skovronsky, Eli Lilly CSO

An­a­lysts are quick to pan Eli Lil­ly's puz­zling first cut of pos­i­tive clin­i­cal da­ta for its Covid-19 an­ti­body

Eli Lilly spotlighted a success for one of 3 doses of their closely-watched Covid-19 antibody drug Wednesday morning. But analysts quickly highlighted some obvious anomalies that could come back to haunt the pharma giant as it looks for an emergency use authorization to launch marketing efforts.

The pharma giant reported that LY-CoV555, developed in collaboration with AbCellera, significantly reduced the rate of hospitalization among patients who were treated with the antibody. The drug arm of the study had a 1.7% hospitalization rate, compared to 6% in the control group, marking a 72% drop in risk.

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