Eli Lil­ly wins a quick OK for new sar­co­ma drug olara­tum­ab

Richard Paz­dur, FDA

Eli Lil­ly has won an ac­cel­er­at­ed FDA ap­proval of its soft tis­sue sar­co­ma drug olara­tum­ab with set of pos­i­tive re­sults from a small mid-stage study. Lil­ly plans to sell the drug as Lartru­vo to a slice of pa­tients for front­line use  — the first such ap­proval to come along in decades for this dis­ease.

The drug tar­gets PDGF re­cep­tors which cause tu­mor growth.

The agency’s green light comes just a month af­ter the EU’s CHMP of­fered a pos­i­tive opin­ion about a sim­i­lar move in Eu­rope, set­ting up a like­ly transAt­lantic sweep for Lil­ly, which has been pour­ing re­sources in­to its on­col­o­gy pipeline in re­cent years.

The FDA ap­proved the drug, on­ly its 18th OK so far this year, in com­bi­na­tion with dox­oru­bicin among pa­tients who can’t be treat­ed by ra­di­a­tion or surgery and in a group with a type of STS that can be treat­ed with the chemo an­thra­cy­cline.

“For these pa­tients, Lartru­vo, added to dox­oru­bicin, pro­vides a new treat­ment op­tion,” said Richard Paz­dur, MD, di­rec­tor of the Of­fice of Hema­tol­ogy and On­col­o­gy Prod­ucts in the FDA’s Cen­ter for Drug Eval­u­a­tion and Re­search and act­ing di­rec­tor of the FDA’s On­col­o­gy Cen­ter of Ex­cel­lence. “This is the first new ther­a­py ap­proved by the FDA for the ini­tial treat­ment of soft tis­sue sar­co­ma since dox­oru­bicin’s ap­proval more than 40 years ago.”

Lil­ly, which has be­gun to rack up a few new drug ap­provals af­ter a long drought in the clin­ic, was able to present stats show­ing that the me­di­an sur­vival rate for pa­tients hit 26.5 months for the com­bo com­pared to 14.7 months for pa­tients who re­ceived dox­oru­bicin alone. In­ves­ti­ga­tors al­so post­ed a me­di­an pro­gres­sion-free sur­vival time of 8.2 months for the com­bo com­pared to 4.4 months for pa­tients who re­ceived on­ly dox­oru­bicin. Tu­mor shrink­age reg­is­tered at 18.2 per­cent against 7.5 per­cent.

This OK marks an­oth­er im­por­tant step for­ward for Lil­ly, which had been a peren­ni­al lag­gard in R&D. Lat­er this year Lil­ly will fol­low up with its lat­est round of Phase III da­ta for solanezum­ab, its big ex­per­i­men­tal ther­a­py for Alzheimer’s. Most an­a­lysts ex­pect mixed da­ta at best as Lil­ly looks to break the lock on new Alzheimer’s meds af­ter a decade-long run of fail­ures.

Back in March Lil­ly won an ap­proval for the pso­ri­a­sis drug Taltz (ix­ek­izum­ab) and still faces a de­ci­sion on baric­i­tinib for rheuma­toid arthri­tis as well as the CDK 4/6 drug abe­maci­clib, now sched­uled to wrap a Phase III next year as Lil­ly is forced to wait for the full da­ta set.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.

Sanofi, GSK tout 72% Omi­cron ef­fi­ca­cy in PhI­II tri­al of next-gen, bi­va­lent shot — with an eye to year-end roll­out

Sometimes, being late can give you an advantage.

That’s what Sanofi and GSK are trying to say as the Big Pharma partners report positive results from a late-stage trial of their next-gen bivalent Covid-19 vaccine, which was designed to protect against both the original strain of the SARS-CoV-2 virus and the Beta variant. Specifically, against Omicron, they note, the vaccine delivered 72% efficacy in all adults and 93.2% in those previously infected.

Matt Kapusta, uniQure CEO

In trou­bled Hunt­ing­ton’s space, uniQure’s gene ther­a­py shows ear­ly promise

In randomized clinical trial data from a small number of patients, Dutch biotech uniQure shared that its gene therapy for Huntington’s disease seems to reduce the amount of the mutant protein responsible for the disease over the course of a year.

In seven patients with early-stage Huntington’s — four who got the treatment and three who got a placebo — mutant huntingtin protein levels in the cerebrospinal fluid decreased by an average of just over 50% in patients who got the gene therapy compared to around a 17% drop in patients who got the placebo after a year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.

De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

John Leonard, Intellia CEO

In­tel­li­a's CRISPR pro­gram that ed­its genes di­rect­ly in pa­tients shows dura­bil­i­ty in AT­TR amy­loi­do­sis

The first in vivo CRISPR/Cas9 gene editing program has some new durability data showing sustained reduction of a toxic protein in ATTR amyloidosis at all four dose levels in a small 15-patient study.

Intellia Therapeutics presented the much-anticipated data for its Regeneron-collaborated NTLA-2001 Friday morning, adding to the initial Phase I results it first delivered almost a year ago to the day.

Sen. Thom Tillis (R-NC) (J. Scott Applewhite/AP Images)

Phar­ma-friend­ly sen­a­tor calls on FDA for a third time to show patent pro­tec­tions should­n't be blamed for high drug prices

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”