Its front­line and sin­gle-agent as­pi­ra­tions have been set back, but Bris­tol-My­ers Squibb just took a big step for­ward in its ef­forts to ap­ply its check­point in­hibitor Op­di­vo to liv­er can­cer. The FDA has grant­ed break­through sta­tus and pri­or­i­ty re­view to a com­bi­na­tion, sec­ond-line treat­ment.

The des­ig­na­tion is for Op­di­vo (nivolum­ab) in com­bi­na­tion with Yer­voy (ip­il­i­mum­ab),  for treat­ing ad­vanced he­pa­to­cel­lu­lar car­ci­no­ma (HCC), the most com­mon form of liv­er can­cer. The PD-L1 drug was al­ready ap­proved as a sin­gle-agent, sec­ond-line treat­ment for HCC. A PDU­FA date was set for March 10, 2020 — just 4 months from now.

The US reg­u­la­tor gave the nod based off a Phase I/II tri­al of 620 pa­tients that was com­plet­ed in Jan­u­ary, and for which the fi­nal da­ta will be col­lect­ed in 2021. A 2019 analy­sis showed the com­bi­na­tion pro­duced re­sponse rates just above 30% in three dif­fer­ent dos­ing arms, with one arm show­ing an over­all sur­vival of 22.8 months.

Just two months ago, the NJ-based phar­ma gi­ant an­nounced that Op­di­vo failed to beat Nex­avar (So­rafenib), the stan­dard of care, as a front­line treat­ment for ad­vanced HCC. A vic­to­ry there would have been a ma­jor ad­vance, sig­nal­ing the first ma­jor step for­ward in front­line ad­vanced HCC treat­ment since Bay­er in­tro­duced Nex­avar 12 years ago.

Bris­tol-My­ers will be com­pet­ing with Bay­er’s in­hibitor Sti­var­ga (re­go­rafenib) and Eli Lil­ly’s VEG­FR2 in­hibitor Cyra­mza (ra­mu­cirum­ab) as it looks to cap­ture the sec­ond-line mar­ket. Cyra­mza was ap­proved for HCC in May.

De­spite some bumps, liv­er can­cer has proven a far smoother path than one of the oth­er ma­jor sol­id tu­mor types Bris­tol-My­ers has been work­ing hard to get Op­di­vo ap­proved for non-small cell lung can­cer. A ma­jor set­back in 2016 al­lowed Mer­ck to take the lead, and Bris­tol-My­ers has been strug­gling to catch up ever since.

Most re­cent­ly, though, they tout­ed Phase III da­ta test­ing an Op­di­vo com­bi­na­tion as a front­line ther­a­py against ad­vanced NSCLC. The re­sults showed im­proved over­all sur­vival rate for pa­tients who were giv­en a com­bi­na­tion of Op­di­vo and Yer­voy along­side chemother­a­py, al­though out­side an­a­lysts raised con­cerns about tox­i­c­i­ty.

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.