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.

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.

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.