Dur­ing its earn­ings call yes­ter­day, Re­gen­eron said that the FDA has de­layed its de­ci­sion on Lib­tayo in com­bi­na­tion with chemother­a­py in ad­vanced non-small cell lung can­cer.

“We re­cent­ly were in­formed that an FDA trav­el com­pli­ca­tion re­lat­ing to sched­ul­ing a rou­tine clin­i­cal tri­al site in­spec­tion in East­ern Eu­rope will like­ly de­lay their de­ci­sion un­til af­ter our Sep­tem­ber 19 PDU­FA date,” Re­gen­eron pres­i­dent and CEO Len Schleifer said dur­ing the call.

He added that a new in­spec­tion date has al­ready been sched­uled, so the de­lay shouldn’t be too lengthy and that Re­gen­eron doesn’t “ex­pect it to mean­ing­ful­ly im­pact our launch plans as­sum­ing FDA ap­proval.”

In ear­ly June, Re­gen­eron inked a $1 bil­lion-plus deal with its part­ner Sanofi to buy the ex­clu­sive rights to Lib­tayo, plop­ping down a lofty $900 mil­lion up­front.

Iso­fol’s chemother­a­py-en­hanc­ing drug doesn’t move the nee­dle in ad­vanced col­orec­tal can­cer

Swe­den-based Iso­fol’s lead can­di­date, a chemother­a­py-en­hanc­ing drug, flunked a Phase III study in metasta­t­ic col­orec­tal can­cer, or mCRC, the biotech said Wednes­day.

In al­most 500 pa­tients in the AGENT study, com­pared to leu­cov­orin — which is cur­rent­ly used to com­ple­ment chemother­a­py — Iso­fol’s ar­foli­tixorin did not sig­nif­i­cant­ly change the over­all re­sponse rate, which was the pri­ma­ry end­point, or pro­gres­sion-free sur­vival, the key sec­ondary out­come.

In a press re­lease, Iso­fol CEO Ulf Jungnelius said the biotech was “sur­prised and dis­ap­point­ed” by the tri­al out­come. He added that Iso­fol will first com­plete the da­ta analy­sis and plans to con­sult reg­u­la­to­ry agen­cies in the first half of next year pri­or to de­cid­ing the fate of its lead can­di­date.

The Phase III flunk cratered Iso­fol’s stock, as it dropped some 80% yes­ter­day.

Iso­fol said the full re­sults from the study, in­clud­ing sub­group analy­ses and safe­ty da­ta, will be avail­able lat­er this year. The FDA grant­ed ar­foli­tixorin fast-track des­ig­na­tion in late 2021.

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, just two weeks after submitting a supplemental BLA. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

Rare diseases often have more than just physical effects on patients — especially when it comes to chronic conditions. In the case of the rare slow-growing blood cancer chronic lymphocytic leukemia (CLL), AbbVie wanted to try to assess the mental and emotional toll on patients.

So it surveyed more than 300 CLL patients, caregivers and physicians. While each group differed in how they felt — caregivers overwhelmingly (81%) felt positive about their role, for instance — patients described a “roller coaster” of emotions traversing diagnosis to treatment to remission and even relapse for some.