Pfiz­er brings Ibrance to new sub­set of breast can­cer pa­tients, re­gard­less of menopausal sta­tus

Pfiz­er has ex­pand­ed Ibrance’s use to in­clude a new sub­set of breast can­cer pa­tients, the com­pa­ny slipped in­to its quar­ter­ly earn­ings re­port on Tues­day.

The drug was ap­proved in com­bi­na­tion with an aro­matase in­hibitor (AI) in mid-De­cem­ber to treat women with HR-pos­i­tive, HER2-neg­a­tive metasta­t­ic breast can­cer re­gard­less of menopausal sta­tus, Pfiz­er an­nounced.

Ibrance was first ap­proved in post­menopausal women with ad­vanced breast can­cer back in 2015. The CDK4/6 in­hibitor has since racked up a slate of la­bel ex­pan­sions, but un­til the lat­est add-on, the AI com­bo treat­ment was on­ly in­di­cat­ed for post­menopausal women or men.

Reg­u­la­tors re­quest­ed that Pfiz­er in­clude pre- and per­i­menopausal women in the in­di­ca­tion back in De­cem­ber 2021, prompt­ing the phar­ma gi­ant to file a sup­ple­men­tal new drug ap­pli­ca­tion (sN­DA) last March, ac­cord­ing to an ap­proval let­ter.

“With an es­ti­mat­ed 17% of the HR+/HER2- mBC pop­u­la­tion con­sist­ing of peri/pre-menopausal pa­tients, there re­mained an un­met need for this pa­tient pop­u­la­tion,” Pfiz­er said in an email to End­points News.

Pfiz­er test­ed Ibrance in com­bi­na­tion with ful­ves­trant in women re­gard­less of menopausal sta­tus in the Phase III PALO­MA-3 study, how­ev­er 80% of the 521 pa­tients en­rolled were post­menopausal, ac­cord­ing to the drug’s la­bel. Pa­tients treat­ed with the Ibrance com­bo in that study saw a me­di­an pro­gres­sion-free sur­vival of 9.5 months, com­pared to a me­di­an 4.6 months in the place­bo group.

“Con­sis­tent PFS re­sults were ob­served across pa­tient sub­groups of dis­ease site, sen­si­tiv­i­ty to pri­or hor­mon­al ther­a­py, and menopausal sta­tus,” the la­bel states.

Pfiz­er said the la­bel ex­pan­sion was based on sub­group analy­ses from PALO­MA-3 and PALO­MA-2, an­oth­er Phase III study in which a sub­group of pre- and per­i­menopausal women were treat­ed with Ibrance and letro­zole fol­low­ing an oophorec­to­my. Ev­i­dence was al­so in­clud­ed from an in­ves­ti­ga­tor-ini­ti­at­ed study.

While ex­ec­u­tives did not men­tion the new ap­proval in pre­pared re­marks dur­ing Pfiz­er’s Q4 earn­ings call, CSO Mikael Dol­sten did say that the team ex­pects a piv­otal read­out for Ibrance in HR-pos­i­tive, HER2-pos­i­tive breast can­cer in the next 18 months.

Glob­al Ibrance sales were down 6% last year, to­tal­ing rough­ly $5.1 bil­lion. While the drug has long been a mar­ket leader, ri­vals from Eli Lil­ly and No­var­tis are look­ing to take a bite out of its mar­ket share. Eli Lil­ly’s Verzenio earned $617 mil­lion in Q3, up 84% from the pre­vi­ous year, while No­var­tis’ Kisqali raked in $327 mil­lion, up 49%. Gilead has al­so filed for ap­proval of Trodelvy in pre­treat­ed HR-pos­i­tive, HER2-neg­a­tive metasta­t­ic breast can­cer, and is ex­pect­ing a de­ci­sion this month.

Ed­i­tor’s Note: This sto­ry has been up­dat­ed to in­clude com­ment from Pfiz­er.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Who’s spend­ing and who’s cut­ting from Big Phar­ma’s $127B R&D bud­get? Here are the top 15 play­ers

A couple of the Big 15 biopharma companies in R&D hit the gas on research spending last year. Merck and Sanofi still have lots to prove in the pipeline, and they’re willing to gamble large sums to make a better future for themselves.

Doing nothing would be infinitely worse.

But collectively, the top players rang up a modest 2.4% increase in spending in 2022, which didn’t cover inflationary pressures. And that set the tone for an extraordinarily cautious year for the industry — even as it laid out about $127 billion to advance new drugs or up the ante on approved therapies.

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Jeff Bluestone (R), Sonoma Biotherapeutics CEO

Jef­frey Blue­stone brings his start­up haul to $400M+, join­ing forces with Re­gen­eron on cell ther­a­pies

These days, when Jeffrey Bluestone gets together with his contemporaries in science, the conversation often turns to retirement plans.

But a little more than three years ago, Bluestone reached a momentous turning point in his career, exiting a prestigious post at UCSF, where he had spent decades in the scientific pursuit of new therapies. And it had nothing to do with retirement anytime in the near future.

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Sally Susman, Pfizer EVP and chief corporate affairs officer

Q&A: Pfiz­er cor­po­rate com­mu­ni­ca­tions chief Sal­ly Sus­man dis­cuss­es book craft­ed in pan­dem­ic and per­son­al lessons

From the political arena to the finance and beauty industries to pharmaceuticals, Pfizer’s Sally Susman has broken barriers, stereotypes and conventions. And now the chief communicator is “Breaking Through,” the title of her first book about effective and innovative communications launching today. The full official title is “Breaking Through: Communicating to Open Minds, Move Hearts, and Change the World.”

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Gun­ning for 2023 ap­proval, GSK de­tails PhI­II da­ta for Jem­per­li in front­line en­dome­tri­al can­cer

GSK has a new slate of data to offer on its PD-1 inhibitor, Jemperli — data that the pharma giant hopes will cement one of the four drug approvals it’s expecting this year.

While Jemperli (dostarlimab) is already approved for a subset of patients with second-line endometrial cancer, GSK set out in the Phase III RUBY trial to test it as an earlier line of treatment while also enrolling a broader group of patients. In an interim analysis, Jemperli was shown to extend progression-free survival for both the subset and the overall trial population when added to chemotherapy.

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Es­pe­ri­on sues Dai­ichi Sankyo, de­mand­ing pay­ment of $300M mile­stone for car­dio drug

Esperion is suing its business partner Daiichi Sankyo, saying the Japanese drugmaker is improperly refusing to pay a $300 million milestone that the biotech company will be owed after reporting positive data from a large trial of its cardiovascular drug Nexletol.

The 2019 deal between the companies had Daiichi Sankyo pay $150 million upfront plus another $150 million after the first sales of the drug. But another major payout was tied to an outcomes study reported this month, known as CLEAR. Esperion, in its suit against Daiichi, argues that the drug’s more than 20% reduction of heart attack risk is enough to trigger a $300 million payout from Daiichi once it’s added to the drug’s label.

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Robert Califf, FDA commissioner (Photo by Drew Angerer/Getty Images)

House com­mit­tee to in­ves­ti­gate FDA's re­sponse to on­go­ing drug short­ages

Republican leaders of the House Committee on Energy & Commerce sent a five-page letter yesterday announcing an investigation into the ongoing drug shortages that have rankled the US during the pandemic and the FDA’s response to it.

The letter, signed by Chair Cathy McMorris Rodgers (R-WA), explains how shortages have become more common over the past decade, while pointing to a report from the National Academies of Science, Engineering and Medicine finding that drug shortages have been “on the rise” over the past several decades and are lasting longer, with new drug shortages in the US seeing a 30% increase from 2021 to 2022.

Eli Lil­ly to in­crease in­vest­ment to $1B in­to new Irish man­u­fac­tur­ing fa­cil­i­ty — re­port

The US pharma giant Eli Lilly will be increasing its financial commitment to a manufacturing site in Ireland.

According to a release from Ireland’s Industrial Development Agency (IDA) on Monday, Lilly will be investing another $500 million in its manufacturing facility in Limerick, Ireland — bringing the total investment into the facility to approximately $1 billion.

In January of last year, Lilly announced it was placing a $446 million investment into the site to expand active pharmaceutical ingredient and monoclonal antibody production.

Uğur Şahin, BioNTech CEO (Andreas Arnold/picture-alliance/dpa/AP Images)

BioN­Tech read­ies for plunge in Covid sales, will boost mR­NA and on­col­o­gy pipelines

BioNTech is estimating €5 billion (nearly $5.4 billion) in Covid-19 vaccine sales this year, a marked drop from €17.1 billion ($18.5 billion) in 2022 — and way off analysts’ expectations of around €8 billion ($8.6 billion).

In BioNTech’s year-end earnings call on Monday, it reported a total of €17.3 billion ($18.7 billion) in 2022 revenue, almost all from vaccine sales, which include those via its Pfizer deal and direct sales.

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