As gener­ic com­pe­ti­tion stut­ter sales of top on­col­o­gy drugs, Roche se­cures speedy re­view for pair of ex­per­i­men­tal can­cer of­fer­ings

As drug de­vel­op­ers seek ways to ex­pand ther­a­peu­tic ap­pli­ca­tions and over­come the hur­dles seen with the first gen­er­a­tion of an­ti­body drug con­ju­gates (AD­Cs), Roche is cap­i­tal­iz­ing on its tro­jan horse ADC — pow­ered by Seat­tle Ge­net­ics’ tech­nol­o­gy — as gener­ics eat in­to the sales of its tri­fec­ta of top can­cer drugs. On Tues­day, the Swiss drug­mak­er said its an­ti-CD79b ADC — po­latuzum­ab ve­dotin — had won the FDA’s pri­or­i­ty re­view for use in pa­tients with re­lapsed or re­frac­to­ry dif­fuse large B-cell lym­phoma (DL­B­CL), a field that is with­in the clutch of CAR-T ther­a­pies.

The FDA is ex­pect­ed to make its de­ci­sion by Au­gust 19, Roche said on Tues­day.

Po­latuzum­ab ve­dotin is be­ing re­viewed by the reg­u­la­tor when added to ben­damus­tine and Rit­ux­an (BR). The triplet had pre­vi­ous­ly se­cured break­through ther­a­py sta­tus. The pri­or­i­ty re­view was grant­ed on the ba­sis of an 80-pa­tient study in heav­i­ly pre-treat­ed sub­jects that showed the com­bo eclipsed me­di­an over­all sur­vival (an ex­plorato­ry end­point) com­pared to BR alone, help­ing pa­tients live longer by 12.4 months ver­sus 4.7 months. Da­ta al­so showed 40% of peo­ple treat­ed with po­latuzum­ab ve­dotin plus BR achieved a com­plete re­sponse (CR), while on­ly 18% of peo­ple treat­ed with BR alone achieved a CR.

The CD79b pro­tein is ex­pressed in the ma­jor­i­ty of types of B-cell non-Hodgkin lym­phomas, the most com­mon sub­type of NHL. Al­though pa­tients are gen­er­al­ly re­spon­sive to first­line treat­ment, as many as 40% of pa­tients re­lapse, af­ter which op­tions are lim­it­ed and sur­vival is short. Po­latuzum­ab ve­dotin, which is be­ing test­ed for use in sev­er­al types of NHL, binds to CD79b and dec­i­mates B-cells via a tar­get­ed ap­proach: min­i­miz­ing the ef­fects on healthy cells while max­i­miz­ing tu­mour cell death, us­ing ADC tech that is some­times likened to a tro­jan horse as it is en­gi­neered to go un­no­ticed, de­liv­er­ing chemother­a­pies to cells ex­press­ing the anti­gen tar­get.

Sep­a­rate­ly, Roche has al­so won a pri­or­i­ty re­view for en­trec­tinib, a drug for use in neu­rotroph­ic tropomyosin re­cep­tor ki­nase (NTRK) fu­sion-pos­i­tive, lo­cal­ly ad­vanced or metasta­t­ic sol­id tu­mors in pa­tients whose can­cer has pro­gressed de­spite ther­a­py as well as pa­tients with metasta­t­ic ROS-1 pos­i­tive non-small cell lung can­cer (NSCLC).

The FDA is ex­pect­ed to make its de­ci­sion on the drug, which has pre­vi­ous­ly se­cured break­through ther­a­py sta­tus, by Au­gust 18, Roche said.

Roche, which bagged en­trec­tinib late in 2017 with its $1.7 bil­lion Igny­ta buy­out, hopes the drug will fare well ver­sus Bay­er’s Vi­t­rakvi — the first drug ap­proved by the FDA for NTRK fu­sion can­cers and the run­ner up ’tis­sue ag­nos­tic’ can­cer treat­ment that won the US reg­u­la­to­ry nod. With­in NSCLC, en­trec­tinib will be up against Pfiz­er’s Xalko­ri, which is the stan­dard treat­ment in ROS-1 pos­i­tive pa­tients.

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.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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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.

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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.”

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.

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.”

EMA signs off on 3 drugs re­cent­ly re­ject­ed by FDA, in­clud­ing Bio­Mar­in's new he­mo­phil­ia gene ther­a­py

The EMA’s human medicines committee on Friday recommended three new drugs for approval or conditional approval, even as their US counterparts have rejected these three for various reasons.

In a major move, CHMP offered a thumbs-up to a conditional marketing authorization for the first gene therapy to treat severe hemophilia A, although the agency cautioned that it’s so far unknown how long the effects of infusion will last.

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Joe Papa (Ryan Remiorz/The Canadian Press via AP, File)

Joe Pa­pa re­signs as chair of Bausch Health as bil­lion­aire John Paul­son takes over

Joe Papa, chair of Bausch Health, officially resigned on Thursday and the board appointed billionaire hedge fund manager John Paulson as the new chair, effective immediately.

The specialty pharma company sought to make clear that Papa’s abrupt departure “was not due to any dispute or disagreement with the Company, its management or the Board on any matter relating to the Company’s operations, policies or practices.”

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