Af­ter a decade, a sec­ond CT­LA-4 an­ti­body may fi­nal­ly be on its way to ap­proval.

As­traZeneca an­nounced Mon­day that the FDA had giv­en pri­or­i­ty re­view to treme­li­mum­ab, its long-ges­tat­ing CT­LA-4 an­ti­body, in com­bi­na­tion with the PD-L1 in­hibitor Imfinzi for pa­tients with liv­er can­cer that can’t be treat­ed with surgery.

The Big Phar­ma’s ap­pli­ca­tion is based on a mul­ti-year, 1,324-pa­tient study that showed 30.7% of pa­tients who re­ceived a “prim­ing dose” of treme­li­mum­ab fol­lowed by Imfinzi were alive af­ter three years, com­pared to 20.2% of pa­tients who re­ceived Bay­er’s so­rafenib, the stan­dard of care.

Su­san Gal­braith, As­traZeneca’s can­cer R&D chief, called that da­ta “un­prece­dent­ed.” Oth­ers raised ques­tions about how the da­ta held up com­pared to an al­ter­na­tive treat­ment reg­i­men be­ing de­vel­oped by Roche, and how much ben­e­fit the CT­LA-4 an­ti­body of­fered, giv­en that pa­tients who re­ceived Imfinzi alone showed near­ly iden­ti­cal sur­vival at the two-year mark. The dif­fer­ence on­ly emerged af­ter three years.

Nev­er­the­less, the three-year da­ta were no­table giv­en how oth­er PD-1 in­hibitors have done in the same set­ting when test­ed on their own. Op­di­vo failed to show an ad­van­tage over stan­dard of care in one tri­al, and Mer­ck has strug­gled to show that Keytru­da of­fers a mean­ing­ful ad­van­tage ei­ther.

Treme­li­mum­ab has had plen­ty of its own stum­bles. Pfiz­er first put the drug in tri­als in 2004, but aban­doned it soon af­ter, fol­low­ing dis­ap­point­ing ear­ly re­sults. It was still years be­fore Bris­tol My­ers Squibb showed block­ing CT­LA-4 could dra­mat­i­cal­ly ex­tend the lives of a sub­set of melanoma pa­tients, jump­start­ing the im­muno-on­col­o­gy field and mak­ing tens of bil­lions of dol­lars for Mer­ck and Bris­tol My­ers.

As­traZeneca li­censed Pfiz­er’s drug in 2011, hop­ing to get in on the still nascent im­muno-on­col­o­gy field, but it failed con­tin­u­al­ly in tri­als, in­clud­ing in lung, urothe­lial, and head and neck can­cer.

Al­though the drug would on­ly be OK’d for a lim­it­ed in­di­ca­tion, an ap­proval would make it the sec­ond CT­LA-4 an­ti­body on the mar­ket and the first con­tender to Bris­tol My­ers’ Yer­voy since it was ap­proved in 2011.

As­traZeneca is al­so hop­ing to get an ap­proval soon in com­bi­na­tion with Imfinzi in metasta­t­ic lung can­cer, al­though it is un­clear how much ben­e­fit the new drug of­fers over Imfinzi alone.

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.

The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.

Sage Chemical won the first generic approval for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.

The White House’s Office of Science and Technology Policy (OSTP) last year sought to find ways to better coordinate large-scale clinical trials in the US — as the UK lead by example during the pandemic — especially for these emergency clinical trials.

The lobbying group PhRMA Tuesday called for more clinical trial diversity in underserved areas, including by making participation less of a burden, and expanding eligibility criteria when appropriate.