FDA OKs Tesaro’s ni­ra­parib for ovar­i­an can­cer, hand­ing the biotech a big win on the la­bel

The FDA has wast­ed no time in giv­ing Tesaro $TSRO a broad ap­proval for the use of its PARP drug ni­ra­parib, which will now be mar­ket­ed as Ze­ju­la as a main­te­nance ther­a­py for re­cur­rent ovar­i­an can­cer.

The OK and the la­bel that came with it rep­re­sents a set­back for Myr­i­ad Ge­net­ics $MYGN, which had ar­gued that its com­pan­ion di­ag­nos­tic would be need­ed to iden­ti­fy a spe­cif­ic group of ovar­i­an can­cer pa­tients with a bio­mark­er in­di­cat­ing that they would most like­ly ben­e­fit. But reg­u­la­tors blew past any di­ag­nos­tic qual­i­fi­ca­tion in giv­ing Tesaro the la­bel that it was look­ing for, vin­di­cat­ing CEO Lon­nie Moul­der’s vow that he could get an OK aimed at a large seg­ment of the mar­ket.

Tesaro had ar­gued that the ef­fi­ca­cy da­ta for ni­ra­parib qual­i­fied for an ap­proval for use in pa­tients who are ei­ther HRD pos­i­tive or HRD neg­a­tive. But they were op­posed by a part­ner who had a sol­id busi­ness case for ar­gu­ing that the drug should be re­served for pa­tients who would be most like­ly to ben­e­fit.

In the end, though, Tesaro is left with a big boast in its fa­vor: “Ze­ju­la is the on­ly PARP in­hibitor that has demon­strat­ed a clin­i­cal­ly mean­ing­ful in­crease in pro­gres­sion-free sur­vival (PFS) in women with re­cur­rent ovar­i­an can­cer, re­gard­less of BR­CA mu­ta­tion or bio­mark­er sta­tus.”

The OK al­so helps po­si­tion Tesaro against As­traZeneca, which just de­liv­ered stel­lar Phase III da­ta on its PARP Lyn­parza. Clo­vis, mean­while, gained an ap­proval for its PARP Rubra­ca late last year as a treat­ment for BR­CA-mu­tat­ed ovar­i­an can­cer that had proved re­sis­tant to at least two pri­or ther­a­pies.

It’s a trans­for­ma­tion­al mo­ment for Tesaro. Its drug was list­ed by Eval­u­atePhar­ma as one of the top drugs in the in­dus­try’s pipeline this year, with peak sales ex­pec­ta­tions hov­er­ing close to $2 bil­lion a year. And its stock climbed about 6% in af­ter-mar­ket trad­ing.

The ap­proval came months ahead of the FDA’s PDU­FA dead­line in June, in­di­cat­ing its in­ter­est and un­der­stand­ing of the field.

Mary Lynne Hed­ley, Tesaro

Ze­ju­la’s la­bel notes that it is in­di­cat­ed for the main­te­nance treat­ment of adult pa­tients with re­cur­rent ep­ithe­lial ovar­i­an, fal­lop­i­an tube, or pri­ma­ry peri­toneal can­cer who are in a com­plete or par­tial re­sponse to plat­inum-based chemother­a­py. And Tesaro im­me­di­ate­ly fol­lowed the news of the OK with plans to open up on the R&D pro­gram for the drug.

“Based on the un­prece­dent­ed re­sults of the NO­VA tri­al in women with re­cur­rent ovar­i­an can­cer, we pre­vi­ous­ly an­nounced the ex­pan­sion and re­fine­ment of our PRI­MA and QUADRA tri­als to in­clude a broad pa­tient pop­u­la­tion, and in the case of PRI­MA, elim­i­nat­ed the en­roll­ment re­quire­ment for a bio­mark­er se­lect­ed tu­mor. With the ap­proval of ZE­JU­LA in hand, we will now be­gin to ex­e­cute on our plans to pur­sue po­ten­tial­ly trans­for­ma­tion­al ap­pli­ca­tions of ni­ra­parib in a broad range of metasta­t­ic can­cer in­di­ca­tions,” said Mary Lynne Hed­ley, pres­i­dent and COO of TESARO. “We plan to ex­pand our first-line ovar­i­an can­cer strat­e­gy to in­clude a com­bi­na­tion study that as­sess­es the po­ten­tial ben­e­fit of ni­ra­parib plus an an­ti-PD-1 an­ti­body in the main­te­nance set­ting and ini­ti­ate a clin­i­cal study of ni­ra­parib in com­bi­na­tion with be­va­cizum­ab in pa­tients with a first re­cur­rence of ovar­i­an can­cer, with an in­tent to re­place chemother­a­py in this set­ting. We re­main strong­ly com­mit­ted to study­ing ni­ra­parib in the breast can­cer set­ting and al­so ex­pect to ini­ti­ate a new tri­al of ni­ra­parib in com­bi­na­tion with an an­ti-PD-1 an­ti­body in women with metasta­t­ic triple-neg­a­tive breast can­cer. Fi­nal­ly, our goal to move ni­ra­parib in­to in­di­ca­tions be­yond ovar­i­an and breast can­cers en­com­pass­es plans to ini­ti­ate a reg­is­tra­tion strat­e­gy for the first-line treat­ment of pa­tients with metasta­t­ic non-small cell lung can­cer that in­cludes a phase 2 tri­al of ni­ra­parib in com­bi­na­tion with an an­ti-PD-1 an­ti­body in pa­tients, re­gard­less of PDL-1 tu­mor ex­pres­sion, and a phase 3 tri­al of ni­ra­parib in com­bi­na­tion with an an­ti-PD-1 an­ti­body in pa­tients with high lev­els of PDL-1 tu­mor ex­pres­sion.”

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; 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.

Over the last four years, we’ve honored 80 women whose extraordinary accomplishments have changed the game in biopharma R&D. You can now nominate someone to be highlighted in this year’s special report. Details are here.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

Eu­ro­pean doc­tors di­al up dig­i­tal com­mu­ni­ca­tion with phar­mas, but still lean to­ward in-per­son med meet­ings, study finds

As in-person sales rep access declines in the big five European countries, a corresponding uptick in virtual rep access is happening. It’s not surprising, but it does run counter to pharma companies’ assessment – along with long-held sales rep sway in Europe – that in-person access hadn’t changed.

CMI Media Group and Medscape’s recent study reports that 75% of physicians in the EU5 countries of Spain, Germany, Italy, France and the UK already limit engagements with pharma sales reps, and 25% of those surveyed plan to decrease time with reps.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

Judge al­lows ex­pert tes­ti­mo­ny in GSK tri­al al­leg­ing Zan­tac link to can­cer

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.

The Melon family, as seen in Concussion Awareness Now's latest campaign

Ab­bott in­tro­duces the Mel­on fam­i­ly to raise con­cus­sion aware­ness

Abbott is renewing its concussion awareness campaign, weeks after the company received FDA clearance for its lab-based traumatic brain injury (TBI) blood test.

The unbranded campaign features three generations of the Melon family — animated talking melons who slip on toys or take a spill while playing pickleball.

“Don’t mess with your melon. If you hit it, get it checked,” a narrator says.