Lung can­cer is the are­na where As­traZeneca’s Imfinzi has made its mark, but those who have watched the PD-L1 drug since it was still known as dur­val­um­ab might re­mem­ber that its very first FDA OK — an ac­cel­er­at­ed ap­proval grant­ed in May 2017 — was for blad­der can­cer.

Un­til to­day.

Af­ter “con­sul­ta­tion with the FDA,” As­traZeneca says it has vol­un­tar­i­ly with­drawn this in­di­ca­tion in the US, mean­ing it will no longer be mar­ket­ing it to pa­tients with lo­cal­ly ad­vanced or metasta­t­ic blad­der can­cer who have been treat­ed with chemother­a­py. Pa­tients cur­rent­ly on the ther­a­py are ad­vised to con­sult with their doc­tors.

The with­draw­al comes al­most a year af­ter Imfinzi flunked a con­fir­ma­to­ry tri­al dubbed DANUBE, fail­ing to help pa­tients live longer com­pared to chemo alone. The ac­cel­er­at­ed OK had been based on tu­mor re­sponse rate and du­ra­tion of re­sponse.

Dave Fredrick­son

Dave Fredrick­son, EVP of the on­col­o­gy busi­ness unit, cush­ioned the news by high­light­ing that im­munother­a­pies have been bring­ing new treat­ment op­tions “at an un­prece­dent­ed pace” over the past few years.

“While the with­draw­al in pre­vi­ous­ly treat­ed metasta­t­ic blad­der can­cer is dis­ap­point­ing, we re­spect the prin­ci­ples FDA set out when the ac­cel­er­at­ed ap­proval path­way was found­ed and re­main com­mit­ted to bring­ing new and in­no­v­a­tive op­tions to pa­tients,” he said. “In the last three years, Imfinzi has be­come an im­por­tant stan­dard of care in mul­ti­ple lung can­cer set­tings, an area of con­sid­er­able fo­cus for As­traZeneca.”

The com­pa­ny not­ed that the with­draw­al doesn’t im­pact the in­di­ca­tion out­side the US; it had put an EU fil­ing on the back­burn­er af­ter the CHMP de­cid­ed against a speedy re­view back in 2017.

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.

DC District Court Judge Christopher Cooper today granted Vanda Pharma’s request to require the FDA to disclose more info on the complete response letter for its sleep disorder drug Hetlioz.

The melatonin receptor agonist is approved by the FDA to treat non-24-hour sleep-wake disorder, a circadian rhythm disorder. But in 2018 Vanda filed a supplemental application to market Hetlioz as a treatment for jet lag, which the FDA rejected in August 2019, with few details on what Vanda needed to correct course, according to the company.