Roche pulls dan­gling ac­cel­er­at­ed ap­proval for Tecen­triq in triple-neg­a­tive breast can­cer

Roche on Fri­day de­cid­ed to vol­un­tar­i­ly pull an in­di­ca­tion won via the FDA’s ac­cel­er­at­ed ap­proval path­way for its block­buster PD-L1 drug Tecen­triq.

This is the third ac­cel­er­at­ed ap­proval to be pulled fol­low­ing an ODAC meet­ing last April to re­view six in­di­ca­tions from Roche, Mer­ck and Bris­tol My­ers Squibb block­buster can­cer drugs, where con­fir­ma­to­ry tri­als failed. This is al­so the fourth ac­cel­er­at­ed ap­proval to be pulled in the last month.

The move to pull Tecen­triq in com­bi­na­tion with chemo for the treat­ment of adults with un­re­sectable lo­cal­ly ad­vanced or metasta­t­ic triple-neg­a­tive breast can­cer comes af­ter the FDA’s on­co­log­ic drugs ad­comm vot­ed 7-2 to keep it dan­gling, while oth­er, ad­di­tion­al con­fir­ma­to­ry tri­als were on­go­ing.

But Roche said it came to its de­ci­sion af­ter re­cent con­ver­sa­tions with FDA on an­oth­er post­mar­ket­ing tri­al, and “due to the re­cent changes in the treat­ment land­scape,” which the com­pa­ny said means that the FDA “no longer con­sid­ers it ap­pro­pri­ate to main­tain the ac­cel­er­at­ed ap­proval.”

With lim­it­ed oth­er treat­ment op­tions at the time, Tecen­triq ini­tial­ly won its ac­cel­er­at­ed OK in com­bi­na­tion with nab-pa­cli­tax­el for adult pa­tients with mTNBC whose tu­mors ex­press PD-L1 in March 2019, based on a me­di­an pro­gres­sion-free sur­vival of 7.4 months, which com­pared with 4.8 months for those on place­bo in com­bo with nab-pa­cli­tax­el.

But the con­fir­ma­to­ry tri­al did not pan out and even showed a wor­ri­some sign as the place­bo out­per­formed the treat­ment com­bo in terms of over­all sur­vival.

Laleh Amiri-Ko­rdestani, di­vi­sion di­rec­tor at the Of­fice of On­co­log­ic Dis­eases, pre­sent­ed for the FDA at the ODAC meet­ing and not­ed the over­all sur­vival re­sults in the ini­tial tri­al (on which the ac­cel­er­at­ed ap­proval was based) may have been due to chance alone, and that the ben­e­fit seen in the first tri­al was not cor­rob­o­rat­ed in a sim­i­lar pop­u­la­tion in the con­fir­ma­to­ry tri­al.

Roche em­pha­sized that Fri­day’s de­ci­sion on­ly im­pacts the mTNBC in­di­ca­tion in the US and does not af­fect oth­er ap­proved in­di­ca­tions for Tecen­triq in the US and out­side the US. In 2020, Tecen­triq brought in al­most $3 bil­lion in world­wide sales.

Al­so fol­low­ing that high-stakes April ODAC meet­ing, Mer­ck last month agreed to pull a third-line stom­ach can­cer in­di­ca­tion for its block­buster Keytru­da, which re­ceived a thumbs down from ODAC af­ter late-stage con­fir­ma­to­ry tri­als failed to show clin­i­cal ben­e­fit. And Bris­tol My­ers late last month al­so pulled an in­di­ca­tion re­viewed by ODAC for Op­di­vo as a monother­a­py for he­pa­to­cel­lu­lar car­ci­no­ma pa­tients who have pre­vi­ous­ly been treat­ed with so­rafenib.

Over­all, the out­side ex­perts vot­ed to rec­om­mend pulling two of the six in­di­ca­tions re­viewed, both of which have now been pulled, in ad­di­tion to Roche’s de­ci­sion. It re­mains un­known what may come for the oth­er two in­di­ca­tions re­viewed at the meet­ing.

Sep­a­rate­ly, Bris­tol My­ers in ear­ly Au­gust al­so pulled an Is­to­dax in­di­ca­tion in pe­riph­er­al T cell lym­phoma af­ter a Phase III con­fir­ma­to­ry study for the drug flopped on its pro­gres­sion-free sur­vival end­point.

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

David Baker working with a student on their protein design (Jason Mast)

Sci­en­tists are fi­nal­ly learn­ing how to de­sign pro­teins from scratch. Drug de­vel­op­ment may nev­er be the same

SEATTLE — It’s a cloudy Thursday afternoon in mid-July and David Baker is reclining into the futon in his corner office at the University of Washington, arms splayed out like a daytime talk show host as he coaches another one of his postdocs through the slings and arrows of scientific celebrity.

“Be jealous of your time,” he says, before plotting ways of sneaking her out of Zooms. “It’s this horrible cost to science that you’re tied up in some stupid meeting.”

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Patty Murray, D-WA (Graeme Sloan/Sipa USA)(Sipa via AP Images)

Sen­ate user fee reau­tho­riza­tion bill omits ac­cel­er­at­ed ap­proval re­forms, shows wide gaps with House ver­sion

The Senate health committee on Tuesday released its first version of the bill to reauthorize all the different FDA user fees. But unlike the House version, there are only a few controversial items in the Senate’s version, which does not address either accelerated approval reforms or clinical trial diversity (as the House did).

While it’s still relatively early in the process of finalizing this legislation (the ultimate statutory deadline is the end of September), the House and Senate, at least initially, appear to be starting off in different corners on what should be included.

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Pre­sent­ing a live End­points News event: Man­ag­ing a biotech in tur­bu­lent times

Biotech is one of the smartest, best educated industries on the planet. PhDs abound. We’ve had a long enough track record to see a new generation of savvy, experienced execs coming together to run startups.

And in these times, they are being tested as never before.

Biotech is going through quite a rough patch right now. For 2 years, practically anyone with a decent resume and some half-baked ideas on biotech could start a company and get it funded. The pandemic made it easy in many ways to pull off an IPO, with traditional road shows shut down in exchange for a series of quick Zoom meetings. Generalist investors flocked as the numbers raised soared into the stratosphere.

FDA lob­bies Con­gress over rare dis­ease court rul­ing with wide im­pli­ca­tions

Usually reserved for making decisions on drug applications or enforcing what Congress stipulates, the FDA is now dipping its toe into the wild world of congressional politics as it attempts to fix a major court decision that could have a chilling effect on rare disease R&D.

The case in question from last October saw a US appeals court overturn a prior FDA court win, saying that the agency never should’ve approved a rare disease drug because a previously approved but more expensive drug with the same active ingredient has orphan drug exclusivity barring such an approval.

Peter Marks (Greg Nash/Pool via AP)

Even FDA's Pe­ter Marks is wor­ried about the com­mer­cial vi­a­bil­i­ty of gene and cell ther­a­pies

When bluebird bio’s gene therapy to treat beta thalassemia won European approval in 2019, the nearly $2 million per patient price tag for the potential cure seemed like a surmountable hurdle.

Fast forward two years later, and bluebird has withdrawn Zynteglo, the beta thal drug, along with the rest of its gene therapy portfolio from Europe, which the company said is generally unwilling to pay a fair price for the treatment.

Pri­cy in­halers re­main ex­pen­sive due to de­vice tweaks that keep com­peti­tors at bay, re­searchers find

New research published in Health Affairs today highlights the way in which the FDA’s inhaler regulations have rewarded incremental adjustments to older products, thereby enabling companies to skirt around cheaper competition.

A DC appeals court clerk and researchers from Harvard and the University of Calgary dug through all the patents and regulatory exclusivities granted to inhalers approved by the FDA between 1986 and 2020, finding that of the 62 inhalers approved, 53 (or 85%) were brand-name products, with a median of 16 years of protection from generic competition.

Warren Buffett, Berkshire Hathaway CEO

Berk­shire Hath­away pulls out of Ab­b­Vie, Bris­tol My­ers Squibb in­vest­ments

It looks like Warren Buffett is sticking to ice cream and railroads for the moment.

The billionaire CEO of Berkshire Hathaway backed out of two major holdings in the pharma industry, Forexlive first reported, including a $410 million investment in AbbVie and a $324.4 million stake in Bristol Myers Squibb.

The move comes after Berkshire abandoned its Teva shares just last quarter, Bloomberg reported.

Amidst R&D reshuf­fle, Ver­tex ex­pands its pres­ence in Boston, aim­ing to be­come num­ber one

Vertex Pharmaceuticals has been one of the buzzier names in the bustling Boston biotech scene, but now the company is looking to vault to number one status — at least in terms of physical footprint.

At a ribbon cutting on Tuesday for its new Jeffrey Leiden Center for Cell and Genetic Therapies at the Boston Seaport, Vertex announced it would embark on a new project: The company will build a 344,000 square foot facility in the seaport to accommodate the company’s growing R&D needs, especially in its cell and gene therapies program.

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